Health Care Policy Update – Weekly Wrap-up and What’s Ahead – June 21, 2022

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

COVID-19 Surveillance, Funding, Oversight and Data –

• Data: To date, there are 85,921,461 total COVID-19 cases and 1,008,196 COVID-19 deaths in the United States. Also, 758,129,055 COVID-19 vaccines have been delivered and 592,269,252 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. (Monday Update)
• On June 16, the FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. Press Release

Medicare, Medicaid & Marketplaces –

• On June 13, CMS released the 2020 Medicaid Managed Care Enrollment Report, which provides plan-specific enrollment statistics on Medicaid managed care programs. The Report includes statistics, in point-in-time counts, on enrollees receiving comprehensive and limited benefits. The Report also includes plan name, managed care entity, reimbursement arrangement, operating authority, geographic area served, number of enrollees by plan and dual eligible by plan. Press Release Enrollment Summary
• Also on June 13, HHS released a technical report, in contract with RAND Health Care, that describes methods applied for imputing race and ethnicity among people who selected Marketplace plans on HealthCare.gov but did not report their race or ethnicity, and applied these methods to data from the 2015 to 2022 Open Enrollment Periods. The report also presents summary enrollment statistics post imputation. Press Release Cover Page Full Report
• Also on June 13, HHS Office of the Inspector General (OIG) released a report in response to earlier Medicare Payment Advisory Commission reports to Congress as well as a previous OIG report. OIG found that both the Medicare program and its beneficiaries could have realized significant savings for evaluation and management services if those services had been paid as if provided at freestanding facilities. Press Release Report Report in Brief
• On June 14, HHS OIG released a memorandum report with performance data for the Senior Medicare Patrol (SMP) projects, which receive grants from the Administration for Community Living (ACL) to recruit and train retired professionals and other older adults and community members to recognize and report instances or patterns of health care fraud. OIG found that the COVID-19 pandemic continued to present challenges for the SMP projects that limited their in-person activities. Press Release Report
• On June 15, HHS OIG released a report on inaccuracies in Medicare’s race and ethnicity data in Medicare’s enrollment database which hinder the ability to assess health disparities. OIG found that Medicare’s enrollment race and ethnicity data are less accurate for some groups, particularly for beneficiaries identified as American Indian/Alaska Native, Asian/Pacific Islander, or Hispanic. Press Release Report
• Also on June 15, the Medicare Payment Advisory Commission (MedPAC) released its June 2022 Report to the Congress: Medicare and the Health Care Delivery System. The report contains seven chapters but does not include any formal recommendations to Congress. Press Release Report
• Also on June 15, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its June 2022 Report to Congress. The report recommending a series of measures that Congress could take to enhance the system for monitoring access to care for Medicaid beneficiaries, improve the oversight and transparency of managed care directed payments, increase access to vaccines for adults enrolled in Medicaid, encourage the uptake of health information technology (IT) in behavioral health, and better integrate care for people who are eligible for both the Medicaid and Medicare programs. Press Release Report
• On June 16, CMS announced that 253,000 parents have gained access to 12 months of postpartum coverage through Medicaid and Children’s Health Insurance Program (CHIP) extensions. CMS approved actions in Maine, Minnesota, New Mexico, and Washington, D.C., to extend Medicaid and CHIP coverage for 12 months after pregnancy. Press Release HHS Press Release
• Also on June 16, HHS OIG officials published an op-ed in STAT on their new study related to Medicare patient safety. OIG found that 25 percent of Medicare beneficiaries experienced harm during inpatient hospital stays, almost half of which could have been prevented by better care. Press Release Study Article
• On June 17, CMS issued the calendar year (CY) 2023 Home Health Prospective Payment System (HH PPS) Rate Update proposed rule, which would update Medicare payment policies and rates for home health agencies (HHAs). This rule includes proposals and routine updates to the Medicare Home Health PPS and the home infusion therapy services’ payment rates for CY 2023. Comments are due by August 16, 2022. Press Release Proposed Rule

• On June 16, the Federal Trade Commission (FTC) announced that it will ramp up enforcement against any illegal bribes and rebate schemes that block patients’ access to competing lower-cost drugs. The enforcement policy statement puts drug and prescription drug companies on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws. Press Release Enforcement Policy Statement
• Also on June 16, the United States Supreme Court handed down a unanimous opinion, AHA v. Becerra, which confirmed that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure in 2018 and 2019 that resulted in certain 340B hospitals receiving lower Part B drug reimbursement than non-340B hospitals. Opinion
• Also on June 16, the Food and Drug Administration (FDA) sent to Congress its Report on Drug Shortages for Calendar Year 2021, the ninth annual report to summarize major actions taken by the agency to prevent or mitigate drug shortages in the United States. During CY 2021, there were 41 new shortages, and the FDA helped prevent 317 potential shortages. Report

Health IT & Digital Health –

• On June 13, the Office of the National Coordinator for Health IT (ONC) published a blog post on the third report in the Accelerating Application Programming Interfaces (APIs) report series, which assesses the current landscape of API-based health information exchange. ONC presents perspectives of app developers and data integrators to better understand the emerging landscape of technology companies and their role in effective data aggregation, integration, and exchange. Blog Post Report
• On June 13, HHS Office of Civil Rights (OCR) issued guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth is no longer in effect. Press Release
• On June 14, ONC published a Notice of Funding Opportunity (NOFO) on the Leading Edge Acceleration Projects (LEAP) in Health IT. This funding opportunity will address well-documented and fast emerging challenges that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. Applications are due August 15, 2022. Press Release NOFO
• On June 15, ONC published a blog post about convening stakeholders working with artificial intelligence (AI) and machine learning technologies through public events such as AI showcase, a Health Information Technology Advisory Committee (HITAC) hearing on algorithmic bias, and session on equity and algorithms at its annual meeting. ONC is also actively monitoring and engaged in health and AI-focused initiatives such as the Coalition for Health AI and in a number of cross-agency coordination efforts with federal partners. Blog Post
• On June 16, ONC published a blog post announcing the launch of the HITAC Adopted Standards Task Force, which will review and make recommendations on the existing set of ONC-adopted standards and implementation specifications. The final report from the task force and recommendations from HITAC are expected in the fall of 2022. Blog Post

Mental Health and Substance Use Disorder Policy –

• On June 15, Senate Finance Committee Chair Wyden (D-OR), Ranking Member Crapo (R-ID), Senator Carper (D-DE) and Senator Cassidy (R-LA) released a discussion draft for youth mental health care policies as a part of the Committee’s ongoing work to improve mental health care, which has included a public call for comments and four hearings to help develop these initiatives. Press Release Discussion Draft
• Also on June 15, the U.S. Government Accountability Office (GAO) released preliminary observations on the 2022 National Drug Control Strategy. GAO was unable to identify whether the strategy addressed statutorily required information on performance evaluation planning, estimates of resources needed to achieve goals, and a systematic plan for increasing data collection. Press Release Report Highlights
• On June 17, HHS announced the availability of $10 million in substance misuse grant funding through the HRSA Rural Communities Opioid Response Program. This funding will help rural communities establish new treatment access points to connect individuals to medication to treat opioid use. Press Release
• Also on June 17, HHS announced that United States Surgeon General Dr. Vivek Murthy joined youth leaders, celebrities, community organizers, and others at the California Endowment’s Youth Mental Wellness Now! Summit. The purpose of the Youth Mental Wellness Now! Summit is to create tangible strategies and ideas that can be implemented so that young people feel seen, supported, and heard. Press Release

• On June 13, HHS released a statement on nine Operation Fly Formula Flights. These flights will  import more than four million, eight-ounce bottle equivalents of infant formula to the United States. Press Release
• Also on June 13, Reps. Pallone, Jr. (D-NJ) and Scott (DA-VA) sent a letter urging the FTC to address online marketplaces—including Facebook, eBay, and Amazon—that fail to protect consumers from the fraudulent and deceptive sale of infant formula. Press Release Letter
• On June 14, Senators Murray (D-WA), Cantwell (D-WA),and Casey (D-PA), sent a letter to the FTC to investigate how major retail chains may have engaged in price gouging and raised prices for specialized infant formula amid the nationwide infant formula shortage. Press Release Letter
• On June 15, FDA provided an update on the additional steps it has taken that will lead to the availability of more infant formula in the U.S. under the agency’s recent increased flexibilities. Press Release
• Also on June 15, HHS released a statement on ten Operation Fly Formula Flights. These flights will import nearly five million, eight-ounce bottle equivalents of infant formula to the United States. Press Release
• On June 17, HHS announced that June 16, an Operation Fly Formula flight from Switzerland, arrived at the Louisville International Airport in Louisville, Kentucky, carrying over 44,000 pounds of infant formula, the equivalent of approximately 548,000 eight-ounce bottles. Press Release
• Also on June 17, On June 15, FDA provided an update on the additional steps it has taken that will lead to the availability of more infant formula in the U.S. under the agency’s recent increased flexibilities. Press Release

Misc. –

• On June 14, HHS and the United States Department of Agriculture (USDA) announced a public call for nominations to the 2025 Dietary Guidelines Advisory Committee. This Committee will review scientific evidence to help inform the Dietary Guidelines for Americans, 2025-2030. Members of the public are invited to submit nominations for themselves or other qualified experts by July 15, 2022. Press Release
• On June 15, President Biden issued an Executive Order to combat unlawful discrimination and eliminate disparities that harm LGBTQI+ individuals and their families, defend their rights and safety, and pursue a comprehensive approach to delivering the full promise of equality for LGBTQI+ individuals, consistent with Executive Order 13988 of January 20, 2021 (Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation). Executive Order
• Also on June 15, Senators Murray (D-WA) and Warren (D-MA), led a press conference asking President Biden to issue an executive order to defend Americans’ reproductive rights, including their right to an abortion. Press Release

Legislative Activity –

Votes and Committee Activity –

• On June 14, the Senate HELP Committee marked up five bills. Press release Ranking Member press release
  • The Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) of 2022 (S. 4348) was advanced, without amendment, to the Full Senate by a vote of 13-9.
  • The Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act (S.958) was advanced, without amendment, to the Full Senate by voice vote.
  • The Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act (S.4353) was advanced, without amendment, to the Full Senate by voice vote.
  • The Cardiovascular Advances in Research and Opportunities Legacy Act (H.R. 1193) was advanced, without amendment, to the Full Senate by voice vote.
  • The Early Hearing Detection and Intervention Act of 2022 (S. 4052) was advanced, without amendment, to the Full Senate by voice vote.
• On June 14, Today, Rep. Carolyn B. Maloney, the Chair of the Committee on Oversight and Reform, issued a statement after the Committee voted favorably to approve the LGBTQI+ Data Inclusion Act. The bill would require federal agencies that collect demographic survey data to assess methods for incorporating questions about sexual orientation, gender identity, and variations in sex characteristics into existing surveys. Press Release
• On June 16, the Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2021 (H.R. 3967) passed the Senate by a vote of 84-14. The bill would address health care, presumption of service-connection, research, resources, and other matters related to veterans who were exposed to toxic substances during military service. The bill now moves forward for the President’s signature. Press release

Introduced Legislation –

• On June 13, Rep. Boebert (R-CO) and nine cosponsors introduced the Fentanyl is a Weapons of Mass Destruction (WMD) Act (H.R. 8030), which would require the Assistant Secretary for the Countering Weapons of Mass Destruction Office of the Department of Homeland Security to treat illicit fentanyl as a weapon of mass destruction. Bill text Press release
• Also on June 13, Reps. Johnson (R-SD), Spanberger (D-VA), Bice (R-OK), and Schrier (D-WA) introduced the Formula Shortage Reporting Act of 2022 (H.R. 8038), which would require manufacturers of infant formula to warn about a discontinuance or interruption in the production of infant formula. Bill text Press release
• Also on June 13, Sens. Warner (D-VA) and Scott (R-SC) introduced the Improve Hiring of Caregivers for Seniors Act (S. 4381), which would amend titles XVIII and XIX of the Social Security Act with respect to nursing facility requirements. Bill text Press release
• Also on June 13, Sens. Braun (R-IN) and Hickenlooper (D-CO) introduced the Streamlining Medical Device Updates Act (S. 4386), which would allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Bill text Press release
• On June 14, Reps. Jacobs (D-CA), Fitzpatrick (R-PA), Bass (D-CA), Kim (R-CA), Salazar (R-FL), and McCollum (D-MN) introduced the Reach Every Mother and Child Act of 2022 (H.R. 8057), which would implement policies to end preventable maternal, newborn, and child deaths globally. Press release
• Also on June 14, Reps. Joyce (R-OH), Turner (R-OH), Brown (D-OH), Ross (D-NC), and Ryan (R-OH) introduced the Fighting Post-Traumatic Stress Disorder Act of 2022 (H.R. 8058), which would propose a program for making treatment for post-traumatic stress disorder and acute stress disorder available to public safety officers. Bill text Press release
• Also on June 14, Sens. Ossoff (D-GA) and Cramer (R-ND) introduced the Military Families Mental Health Services Act (S. 4388), which would waive cost-sharing under the TRICARE program for three mental health outpatient visits per year. Bill text Press release
• Also on June 14, Sens. Scott (R-FL) and Lujan (D-NM) introduced the Ryan White PrEP Availability Act (S. 4395), which would allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV. Bill text Press release
• Also on June 14, Sen. Hickenlooper (D-CO) introduced the Transparent Accelerated Approval Act (S. 4390), which would require summary approval information with respect to certain approved drugs and biological products. Bill text Press release
• On June 15, Rep. Green (R-TN) introduced the Reducing Medically Unnecessary Delays in Care Act (H.R. 8078), which would ensure that prior authorization medical decisions under Medicare are determined by physicians. Bill text Press release
• Also on June 15, Reps. Mast (R-FL), Larsen (D-WA), Waltz (R-FL), McMorris Rodgers (R-WA), Miller-Meeks (R-IA), and Franklin (R-FL) introduced the Wounded Warrior Bill of Rights (H.R. 8081), which would preserve the authority of the Secretary of the military department concerned over a member of the Armed Forces undergoing medical treatment or evaluation for medical disability. Bill text Press release
• Also on June 15, Sens. Warren (D-MA), Wyden (D-OR), Murray (D-WA), Whitehouse (D-RI), and Sanders (I-VT) introduced the Health and Location Data Protection Act (S. 4408), which would prohibit data brokers from selling and transferring certain sensitive data. Bill text One Pager Press release
• Also on June 15, Sens. Sinema (D-AZ) and Murkowski (R-AK) introduced the Protecting Social Workers and Human Services Professionals from Workplace Violence Act (S. 4412), which would authorize the Secretary of HHS to award grants to States, Indian Tribes, Tribal organizations, and urban Indian organizations to provide safety measures to social workers, health workers, and human services professionals performing services placing such individuals in high-risk and potentially dangerous situations. Press release
• Also on June 16, Reps. Green (D-TX) and Meng (D-NY) introduced the Stop Taxes Against Menstrual Products (STAMP) Act (H.R. 8107), which would prohibit States from imposing a tax on the retail sale of menstrual products. Press release
• Also on June 16, Rep. Nehls (R-TX) and seven cosponsors introduced the Asylum Claims Improvement Act of 2022 (H.R. 8119), which would amend the Immigration and Nationality Act to limit the ability to take into account the mental health of an applicant for asylum. Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Oversight of Anti-Competitive Behavior of Non-Profit Hospitals Act (H.R. 8129), which would give the Federal Trade Commission authority over certain tax-exempt organizations. Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Competition in State Healthcare Markets Act (H.R. 8130), which would direct the Assistant Secretary for Planning and Evaluation of the Department of HHS to conduct an annual study on health care competition and consolidation at the State level. Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Increasing Competition for Medical Residency Act (H.R. 8131), which would amend the Pension Funding Equity Act of 2004 to repeal the antitrust exemption applicable to graduate medical resident matching programs. Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Flexibility in Hospital Ownership Act (H.R. 8132), which would repeal the Obamacare ban on provider-owned hospitals. Bill text Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Transparency of Hospital Billing Act (H.R. 8133), which would address incorrect billing by off-campus hospital locations. Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Consumer Choice of Care Act (H.R. 8134), which would eliminate the inpatient-only service list. Bill text  Press release
• Also on June 16, Rep. Spartz (R-IN) introduced the Addressing Anti-Competitive Contracting Clauses Act (H.R. 8135), which would require the Government Accountability Office to evaluate the effects of anticompetitive contracting clauses in contracts between health insurers and health care providers and to determine actions taken by the Federal Trade Commission and the Department of Justice relating to the use of such clauses in such contracts and to assess their ability to effectively enforce the Federal antitrust laws with respect to such use. Bill text Press release
• Also on June 16, Sens. Van Hollen (D-MD) and Booker (D-NJ) introduced the Sickle Cell Care Expansion Act (S. 4425), which would authorize a scholarship and loan repayment program to incentivize physicians to enter into the field of sickle cell disease research and treatment. Bill text Press release