Health Care Policy Update – Weekly Wrap-Up and What’s Ahead – July 25, 2022


What’s Ahead: This Week

Hearings & Markups –

  • Tuesday, July 26
    • Senate HELP Committee, “Fighting Fentanyl: The Federal Response to a Growing Crisis.” Additional information
    • House Committee on Rules, “Meeting to Consider H.R. 4040 – Advancing Telehealth Beyond COVID-19 Act of 2021.” Additional information
  • Wednesday, July 27
    • House Veterans’ Affairs Committee, Subcommittee on Technology Modernization, “Protecting our Veterans: Patient Safety and Electronic Health Record Modernization Program.” Additional information
  • Thursday, July 28
    • Senate Special Committee on Aging, “Accessible Federal Technology for People with Disabilities, Older Americans, and Veterans.” Additional information

Notable Policy Events –

  • Monday, July 25 – Tuesday, July 26
  • Monday, July 25
    • Manatt, “In Pursuit of Whole-Person Health: A Review of Drivers of Health Initiatives in Medicaid Managed Care.” Additional information
    • National Academies, “Review of Federal Policies that Contribute to Racial and Ethnic Health Inequities.” Additional information
  • Tuesday, July 26
  • Wednesday, July 27
    • MACPAC, “July 2022 Public Meeting.” Additional information
    • US News and World Report, “How Hospitals are Taking on Shortages and Operational Challenges.” Additional information
    • Committee for a Responsible Federal Budget (CRFB), “Medicare and Inflation.” Additional information
    • Manatt, “The Substance Use Disorder Epidemic Among Youth: Responding to a Growing Mental Health Crisis.” Additional information
    • CMS, “Coverage to Care Partner Webinar: Updated Resources for Understanding Health Coverage.” Additional information
    • United States of Care, “What the Public Health Emergency Unwinding Means for People Enrolled in Medicaid.” Additional information
    • The Hill, “Level Ground: Eliminating Health & Social Disparities.” Additional information
  • Thursday, July 28
    • The Washington Post, “Post-Roe Landscape and the Republican Party.” Additional information
    • Duke-Margolis Center for Health Policy, “North Carolina’s Healthy Opportunities Pilots: Medicaid Managed Care Program to Address Social Needs.” Additional information

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

Medicare, Medicaid & Marketplaces –

  • On July 19, CMS announced an award of $49 million to organizations that work to reduce uninsured rates and connect more children, parents, and families to health care coverage. Grantees will each receive up to $1.5 million over three years to advance Medicaid and CHIP enrollment and retention. Press Release
  • Also on July 19, Representatives Barragán (D-CA), Chu (D-CA), Kelly (D-IL), and Schakowsky (D-IL) led 50 of their colleagues in a letter to Senate Majority Leader Schumer (D-NY) and House Speaker Pelosi (D-CA), urging them to lower the cost of health care and include health care provisions from the House-passed Build Back Better Act (BBB) in an upcoming reconciliation package. Press Release
  • Also on July 19, MedPAC published the annual data book, “Health Care Spending and the Medicare Program,” a chart book that provides tables and graphs describing the Medicare program, Medicare beneficiaries and their utilization of health care services, and Medicare’s payment systems. Data Book
  • On July 20, CMS issued a proposed notice acknowledging the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. Notice
  • Also on July 20, HHS released a report highlighting the impacts of the Affordable Care Act’s Marketplace subsidies on coverage rates among self-employed adults and small business owners, based on tax data from the Department of Treasury and national survey data. Report in Brief Report
  • On July 21, CMS officials penned a blog, published in Health Affairs, regarding the efforts of Medicare in transitioning the health care system away from fee-for-service and towards value-based care through three pillars: alignment, growth, and equity. Blog
  • Also on July 21, HHS released a report that explores key considerations for unifying Medicare-covered post-acute care payment, such as cost-sharing and value-based payment. Report in Brief Report
  • Also on July 21, CMS released the first-ever set of nationally standardized quality measures for Medicaid-funded Home and Community-Based Services (HCBS) that is intended to promote more common and consistent use of nationally standardized quality measures in HCBS programs, create opportunities for CMS and states to have comparative quality data on HCBS programs, and drive improvement in quality of care and outcomes for people receiving HCBS. Press Release Letter to State Medicaid Directors
  • Also on July 21, the Congressional Budget Office and Joint Committee on Taxation released a report that estimates the cost of permanently extending the enhanced ACA plan subsidies. The report estimates this extension would increase the federal deficit by $247.9 billion over a 10-year period, from 2023 through 2032. The enhanced subsidies would also have a net increase of 4.8 million new enrollees to the marketplaces in each year over the same period. Report

Payment & Delivery System Models

  • On July 20, CMS released a white paper which examined evaluation results – including utilization, quality, and cost metrics – across 21 Medicare models and demonstrations to gain a broader understanding of themes by interventions, care settings, provider types, and beneficiary target populations. White Paper Supplemental Document

Public Health Prevention –

  • COVID-19 Data: To date, there are 88,174,283 total COVID-19 cases and 1,015,568 COVID-19 deaths in the United States. Also, 774,307,105 COVID-19 vaccines have been delivered and 597,655,035 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 441 tests under Emergency Use Authorizations (EUAs), including 304 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On July 18, the CDC announced that Sonic Healthcare USA (Sonic) will begin testing for monkeypox using CDC’s orthopoxvirus test, which detects most non-smallpox related orthopoxviruses, including monkeypox. Press Release
  • On July 19, the CDC issued a statement recommending that Novavax’s COVID-19 vaccine be used as another primary series option for adults ages 18 years and older. Press Release
  • Also on July 19, HHS Secretary Becerra issued a statement following the CDC’s recommendation to make the Novavax COVID-19 vaccine available to the American people. Statement
  • Also on July 19, the FDA updated the medical device shortage during COVID-19 list and the device discontinuance list. Updated List
  • Also on July 19, President Biden released a statement on FDA and CDC authorizing Novavax’s COVID-19 vaccine for adults. Statement
  • On July 20, the Agency for Healthcare Research and Quality (AHRQ) requested to revise the currently approved AHRQ Safety Program for Methicillin-Resistant Staphylococcus aureus (MRSA) Prevention, which aims to reduce the incidence and prevalence of infections caused by MRSA in a variety of settings. Notice
  • Also on July 20, Senator Murray (D-WA) sent a letter to HHS Secretary Becerra asking for more information on the Department’s response to the global monkeypox outbreak, and emphasizing the need to learn the lessons of the COVID response and strengthen the public health system. Press Release Letter
  • Also on July 20, Representative Maloney (D-NY) sent a letter to HHS Secretary Becerra expressing concern over the rapidly increasing spread of the monkeypox virus across the U.S. and urging HHS to act swiftly to ensure that vaccines, testing, and treatment are available. Press Release Letter
  • On July 21, HHS issued a fact sheet on the agency’s response to the monkeypox outbreak. HHS has distributed nearly 200,000 JYNNEOS vaccines in recent weeks, accelerated the inspection of approximately 800,000 vaccines for delivery this summer while procuring more for delivery in mid-2023. Press Release
  • On July 22, the FDA released draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency. Press Release

Health IT, Privacy, & Digital Health –

  • On July 19, ONC released the United States Core Data for Interoperability (USCDI) Version 3 (USCDIv3), which expands upon USCDIv2 by adding new data classes and elements. Document
  • On July 20, the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) participated in a coordinated law enforcement action to combat health care fraud. The agencies announced criminal charges for more than $1.2 billion in alleged fraudulent cardiovascular and cancer genetic testing and durable medical equipment (DME) schemes using telehealth-related technology. OIG Alert DOJ Press Release
  • On July 21, Vice President Harris announced that one million new households have signed up to save on home broadband through the Affordable Connectivity Program (ACP). The Vice President sent letters to the nation’s governors describing key steps they can take to boost enrollment in their states. Fact Sheet
  • Also on July 21, the National Institute of Standards and Technology (NIST) updated its cybersecurity guidance for the health care industry. NIST’s new draft publication is designed to help the industry maintain the confidentiality, integrity, and availability of electronic protected health information, or ePHI. Press Release

Mental Health and Substance Use Disorder Policy –

  • On July 18, the Substance Abuse and Mental Health Services Administration (SAMSHA), announced The Disaster Distress Helpline, a 24/7 helpline that provides immediate counseling to anyone who is seeking help in coping with the mental or emotional effects of any mass shooting that has occurred. Press Release
  • On July 19, CDC released key findings from a Vital Signs report on overdose death rates in 2020 by race and ethnicity, treatment access, and income inequality. Overdose death rates increased significantly for Black and American Indian/Alaska Native people. Press Release Briefing
  • On July 21, Senators Hassan (D-NH) and Paul (R-KY) sent a letter to FDA Commissioner Califf urging the FDA to address regulatory ambiguity that may be preventing public health organizations from administering the opioid overdose medication, naloxone. Press Release Letter

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On July 18, a bipartisan group of Representatives sent a letter to the FDA inquiring about steps the agency is taking to approve groundbreaking new therapies for ALS and other deadly diseases and urging the agency to take a rapid approach to approving new life-saving treatments. Press Release Letter
  • On July 19, Congressional members of the Missouri delegation sent a letter to HHS Secretary Becerra in support of locating the Advanced Research Projects Agency for Health (ARPA-H) in the state of Missouri. Press Release
  • Also on July 19, Senate HELP Committee Ranking Member Burr (R-NC) released a fact sheet examining how prescription drug price controls proposed by Democrats will impact biomedical innovation. Fact Sheet
  • On July 21, Representatives Rodgers (R-WA), Guthrie (R-KY), and Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak, asking why the NIH has not convened the Scientific Management Review Board (SMRB) as required by the NIH Reform Act. Press Release Letter
  • Also on July 21, CMS issued a bulletin reminding states and stakeholders of existing federal beneficiary protections that help ensure appropriate beneficiary access to prescription medications, especially as state programs and stakeholders continue to negotiate novel payment arrangements with drug manufacturers. Informational Bulletin

Veterans Health and Military Health  –

  • On July 18, the Department of Veterans Affairs (VA) announced The Veterans Crisis Line, a 24/7 crisis support phone number that links to more than 500 suicide prevention coordinators across the VA health care system. Press Release
  • On July 19, the VA launched an improved Access to Care website to make it easier for Veterans to make informed decisions as they plan their health care appointments. Press Release Website
  • Also on July 19, the VA OIG released a report assessing the Veterans Health Administration’s (VHA) process in responding to a December 2020 medication recall. The OIG determined that the VHA medication recall process generally met VHA requirements. Report in Brief Report
  • On July 21, Representative Bost (R-IL) released a statement after the Senate confirmed Dr. Shereef Elnahal to serve as the VA’s Under Secretary for Health. VA Secretary McDonough approved the establishment of a commission to identify candidates to lead and manage the Veterans Benefits Administration (VBA) in the position of Under Secretary for Benefits. Approval Announcement Statement
  • Also on July 21, OIG released a report that determined whether VBA staff were accurately processing claimed conditions associated with burn pit exposure, as established by VBA policies and procedures during the review period. Report in Brief Report

Health Systems, Public Health & Health Equity –

  • On July 19, FDA Commissioner Califf announced the contracting of external agency experts to conduct a comprehensive evaluation of public-health related programs and partner organizations, including the FDA’s Human Foods Program, The Center for Tobacco Products, and The Reagan-Udall Foundation. Press Release
  • Also on July 19, the U.S. Government Accountability Office (GAO) issued a report recommending a government-wide approach to addressing food-related challenges in the U.S. including diet-related chronic health conditions, foodborne illnesses, and hunger. Report in Brief Report
  • On July 20, the Health Resources and Services Administration (HRSA) announced plans to implement a mixed-methods evaluation to assess the effectiveness of the National Healthy Start Program on individual, organizational, and community-level outcomes. Notice
  • Also on July 20, members of the Congressional Black Caucus Health Braintrust sent a letter to FDA Commissioner Califf in support of the FDA announcement on April 28, 2022 to remove menthol cigarettes from the market. Letter
  • On July 21, the Biden Administration released a fact sheet on actions the Administration has taken to make communities safer, including investing in mental health and substance use treatment services, crisis responders, and social workers to reduce the burden on police officers and prevent violent crime. Fact Sheet
  • On July 22, HHS released a report discussing disparities in health and health care experienced by American Indian and Alaska Native (AI/AN) populations, the role of the federal government in financing and providing health care services to these populations, and how enhanced funding could help further the Indian Health Service’s mission in ensuring that tribal communities have access to high quality health care services. Report in Brief Report

Maternal Health

  • On July 18, the Biden Administration released a statement of administration policy strongly supporting the House passage of H.R. 8373, the Right to Contraception Act, to protect the right to contraception. Statement
  • On July 21, Senator Peters (D-MI) sent a letter urging HHS Secretary Becerra and DHS Secretary Mayorkas to proactively protect reproductive health care rights for U.S. residents following the U.S. Supreme Court’s ruling to overturn Roe v. Wade. Sen. Peters pressed the agencies to clarify guidance on the personal importation of and travel with abortion medication. Press Release Letter

Infant Formula –

  • On July 18, HHS announced five Operation Fly Formula flights throughout the week of July 18. The flights are projected to import more than 6.8 million eight-ounce bottle equivalents of infant formula to the United States. Press Release

Misc. –

  • On July 20, President Biden announced a set of executive actions on climate change including funding for communities that are more prone to natural disasters, lowering cooling costs for communities suffering from extreme heat, and expanding offshore wind opportunities and jobs. Fact Sheet
  • Also on July 20, the White House held a background briefing on the actions president Biden will take to address climate change. Press Briefing

Legislative Activity –

Votes and Committee Activity –

  • On July 19, the House Committee on Veterans’ Affairs held a full committee markup and advanced 18 bills to strengthen health care and benefits for American’s veterans. Press release
  • On July 20, the House Energy & Commerce Committee held a markup of and passed six bipartisan consumer protection bills. Press release
    • The American Data Privacy and Protection Act (H.R. 8152) was passed, as amended, by a vote of 53-2. The bill provides consumers with foundational data privacy rights, creates strong oversight mechanisms, and establishes meaningful enforcement. Bill text Press release
    • The Securing and Enabling Commerce Using Remote and Electronic Notarization Act of 2021 (H.R. 3962) was passed, as amended, by a vote of 56-0. The bill allows a notary public commissioned under state law to remotely notarize electronic records and perform notarizations for remotely located individuals. Bill text
    • The Informing Consumers About Smart Devices Act (H.R. 4081) was passed by a vote of 53-0. The bill requires manufacturers of internet-connected devices that are equipped with a camera or microphone to disclose to consumers that a camera or microphone is part of the device. Bill text
    • The Reporting Attacks from Nations Selected for Oversight and Monitoring Web Attacks and Ransomware from Enemies (RANSOMWARE) Act (H.R. 4551) was passed, as amended, by a vote 53-0. The bill requires the Federal Trade Commission to report on cross-border complaints received that involve ransomware or other cyber-related attacks committed by certain foreign individuals, companies, and governments. Bill text
    • Reese’s Law (H.R. 5313) was passed, as amended, by a vote of 54-0. The bill requires the Consumer Product Safety Commission to establish product safety standards with respect to batteries, such as button cell or coin batteries, that pose an ingestion hazard. Bill text
    • The Manufacturing.gov Act (H.R. 6290) was passed by a vote of 54-0. The bill requires the Department of Commerce to establish a section of the manufacturing.gov website to serve as the primary hub for information relating to federal manufacturing programs. Bill text
  • On July 21, the House passed the Right to Contraception Act (H.R. 8373) by a vote of 228-195. The bill protects a person’s ability to access contraceptives and to engage in contraception, and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception. The bill now goes to the Senate for consideration. Bill text Press release
  • Also on July 21, the President signed the Formula Act (H.R. 8351) into law. The bill suspends tariffs on imported infant formula through December 31, 2022. Bill text Press release

Introduced Legislation –

  • On July 18, Reps. Bush (D-MO), Beyer (D-VA), Omar (D-MN), Jackson Lee (D-TX), McCollum (D-MN), and Norton (D-DC) introduced the Protecting Access to Medication Abortion Act (H.R. 8405), which would preserve access to abortion medications. Bill text One pager Press release
  • Also on July 18, Rep. Ellzey (R-TX) introduced the Federal Mask Mandate Limitations Act (H.R. 8408), which would require a time limitation on covered agency mask mandate requirements. Press release
  • Also on July 18, Sens. Casey (D-PA), Kaine (D-VA), Duckworth (D-IL), and Merkley (D-OR) introduced the (S. 4544), which would provide health equity for people with disabilities. Bill text
  • On July 19, Rep. Bice (R-OK) and 12 cosponsors introduced the (H.R. 8421), which would preempt States from establishing, implementing, or enforcing any ban on the prescription, provision, or use a drug, biological product, or device for contraception if such drug, biological product, or device is approved, licensed, cleared, or otherwise authorized for human use by the Food and Drug Administration for contraception. Bill text
  • Also on July 19, Rep. Davids (D-KS) introduced the Expanding Access to Family Planning Act (H.R. 8424), which would provide enhanced funding for family planning services. Sen. Smith and 36 cosponsors introduced the companion legislation in the Senate (S. 4550). Bill text Press release Senate HELP Press Release
  • Also on July 19, Reps. Hinson (R-IA), Miller-Meeks (R-IA), Mace (R-SC), McMorris Rodgers (R-WA), Smith (R-MO) and five cosponsors introduced the Allowing Greater Access to Safe and Effective Contraception Act (H.R. 8428), which would allow women greater access to safe and effective oral contraceptive drugs intended for routine use. Bill text Press release
  • Also on July 19, Sen. Markey (D-MA) and 31 cosponsors introduced the Right to Contraception Act (S. 4557), which would protect a person’s ability to access contraceptives and to engage in contraception, and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception. Bill text Press release
  • On July 20, Reps. Blumenauer (D-OR), Mace (R-SC), Dean (D-PA), Biggs (R-AZ), and Correa (D-CA) introduced the Right to Try Act (H.R. 8440), which would clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law. Sens. Booker (D-NJ) and Paul (R-KY) introduced the companion legislation in the Senate (S. 4575). Bill text Press release
  • Also on July 20, Reps. Scott (D-VA) and Bonamici (D-OR) introduced the Healthy Meals, Healthy Kids Act (H.R. 8450), which would reauthorize child nutrition programs. Bill text Fact sheet Section by section Press release
  • Also on July 20, Reps. Strickland (D-WA), Fletcher (D-TX), and Bush (D-MO) introduced the Reproductive Health Travel Fund Act (H.R. 8452), which would authorize grants to eligible entities to pay for travel-related expenses and logistical support for individuals with respect to accessing abortion services. Bill text Press release
  • On July 21, Rep. Blumenauer (D-OR) and six bipartisan cosponsors introduced the Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454), which would expand research on cannabidiol and marijuana. Bill text Press release
  • Also on July 21, Reps. Gallego (D-AZ), O’Halleran (D-AZ), and Rice (R-SC) introduced the Preventing Abuse and Neglect of Vulnerable Americans Act (H.R. 8468), which would require the Secretary of Health and Human Services to make certain information available on a public website relating to intermediate care facilities for individuals with intellectual disabilities certified for participation under the Medicaid program. Sens. Kelly (D-AZ) and Sinema (D-AZ) introduced the companion legislation in the Senate (S. 4593). Press release
  • Also on July 21, Reps. Underwood (D-IL), Bera (D-CA), Castor (D-FL), and DeLauro (D-CT) introduced the (H.R. 8481), which would amend the Public Health Service Act with respect to public health data accessibility. Press release
  • Also on July 21, Sens. Rosen (D-NV) and Murkowski (R-AK) introduced the Lactation Spaces for Veteran Moms Act (S. 4580), which would require a lactation space in each medical center of the Department of Veterans Affairs. The House companion bill was passed unanimously in May. Press release
  • Also on July 21, Sens. Booker (D-NJ), Wyden (D-OR), Schumer (D-NY), Murray (D-WA), and Peters (D-MI) introduced the Cannabis Administration and Opportunity Act (S. 4591), which would decriminalize and deschedule cannabis, provide for reinvestment in certain persons adversely impacted by the War on Drugs, and provide expungement of certain cannabis offenses. Bill text Press release