Health Care Policy Update – Weekly Wrap-up and What’s Ahead: May 2, 2022


 

 

What’s Ahead: This Week

Hearings & Markups –

  • Wednesday, May 4
    • Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education and Related Agencies, “Hearing on the FY 2023 Health and Human Services Budget.”
  • Thursday, May 5
    • Senate Committee on Commerce, Science and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security, “Ensuring Fairness and Transparency in the Market for Prescription Drugs.” Additional information

Notable Policy Events –

  • Monday, May 2
    • Bipartisan Policy Center, “Combating the Opioid Crisis with Smarter Federal Spending.” Additional information
  • Wednesday, May 4
    • National Institute for Health Care Management (NIHCM) Foundation, “Mental Health Solutions: Improving Care.” Additional information
  • Friday, May 6
    • Alliance for Health Policy, “Understanding the Medicare Population and Consumer Affordability.” Additional information

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

COVID-19 Surveillance, Funding, Oversight and Data –

  • Data: To date, there are 80,440,151 total COVID-19 cases and 986,042 COVID-19 deaths in the United States. Also, 718,074,545 COVID-19 vaccines have been delivered and 569,397,972 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 431 tests under Emergency Use Authorizations (EUAs), including 297 molecular tests, 84 antibody tests and 50 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On April 25, FDA approved the first COVID-19 treatment Veklury (remdesivir) for children less than two years of age. Press release
  • Also on April 25, Select Subcommittee on the Coronavirus Crisis Chair Clyburn (D-SC), sent a letter to FDA Commissioner Califf requesting a staff briefing on the status of coronavirus vaccine candidates for young children. Press release Letter
  • Also on April 25, Congressional Hispanic Caucus Chair Ruiz (D-CA) sent a letter to President Biden and Vice President Harris with recommended executive actions, including extending the public health emergency through the end of 2022. Press release
  • Also on April 25, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA), Subcommittee on Health Ranking Member Guthrie (R-KY), and Subcommittee on Oversight and Investigations Ranking Member Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Acting Director Tabak requesting the NIH investigate EcoHealth Alliance for possible fraud related to research at the Wuhan lab. Press release Letter
  • On April 26, the Biden Administration released a fact sheet detailing actions to increases access to COVID-⁠19 treatments. The actions include increasing the number of places oral antivirals are available and launching a new effort to stand up federally-supported Test-to-Treat sites. Fact sheet
  • On April 27, GAO released a report recommending fixes to improve health data and address improper payments that current and future federal preparedness requires. Overview Highlights Full report
  • Also on April 27, the Biden Administration released a fact sheet calling for Congress to pass additional COVID-⁠19 response funding. Fact sheet
  • On April 29, FDA announced the schedule for its Vaccines and Related Biological Products Advisory Committee in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers. These include consideration of Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations. Press release

Medicare, Medicaid & Marketplaces –

  • On April 26, Rep. Bourdeaux (GA-07) and Sen. Warnock (D-GA) led 29 representatives and senators in urging Speaker Pelosi, Majority Leader Schumer (D-NY), and Minority Leaders McConnell (R-KY) and McCarthy (R-CA) to include Medicaid expansion in any future reconciliation package. Press release Letter
  • On April 27, CMS released a new report about disparities in health care in Medicare Advantage by race, ethnicity and sex. Of all MA enrollees, 68.2 percent were White; 13.0 percent were Hispanic; 11.9 percent were Black; 4.6 percent were Asian American, Native Hawaiian, or other Pacific Islander; 2.0 percent were Multiracial; and 0.3 percent were American Indian or Alaska Native; and 56.3 percent were female and 43.7 were male. Report
  • On April 28, HHS released the 2023 Notice of Benefits and Payment Parameters Final Rule, which makes regulatory changes in the individual and small group health insurance markets and establishes parameters and requirements issuers need to design plans and set rates for the 2023 plan year. The rule has not yet been posted to the federal register. Press release Fact sheet Final rule
  • Also on April 28, CMS released the January 2022 Medicaid & Children’s Health Insurance Program (CHIP) Enrollment Data Highlights. The report showed 86,953,387 individuals were enrolled in Medicaid and CHIP in the 51 states that reported enrollment data for January 2022. Data
  • Also on April 28, CMS released a 2023 Final Letter to Issuers in the Federally-facilitated Exchanges, which provides updates on operational and technical guidance for the 2023 plan year for issuers. Final letter
  • Also on April 28, HHS Office of the Inspector General (OIG) released a report finding some Medicare Advantage Organization (MAO) denials of prior authorization requests raise concerns about beneficiary access to medically necessary care. Overview Report
  • Also on April 28, CMS released enrollment figures for Medicare. As of January 2022, over 64.2M people are enrolled in Medicare. Data
  • Also on April 28, Ways & Means Ranking Member Rep. Brady (R-TX) and Senate Finance Committee Ranking Member Sen. Crapo (R-ID) sent a letter to Treasury Secretary Yellen expressing concern with the “Family Glitch” proposed rule. Press release Letter
  • Also on April 28, CMS released the Final 2023 Actuarial Value Calculator Methodology to help issuers determine levels of coverage. Methodology Calculator
  • On April 29, CMS released an updated version of the Risk Adjustment Telehealth and Telephone Services during COVID-19 FAQs, which provide clarity around which telehealth services are valid for data submissions for the HHS-operated risk adjustment program. FAQs

Payment and Delivery System Models –

  • On April 26, the CMS Innovation Center released the fourth annual report for the Part D Enhanced Medication Therapy Management Model. The report found that model wide, there were no significant impacts on Gross or Net Medicare expenditures. Summary Report

Mental Health and Substance Use Disorder Policy –

Prescription Drug and Medical Device Policy –

  • On April 25, Sen. Warren (D-MA) sent a letter to HHS Secretary Becerra, urging Secretary Becerra and the Biden Administration to use its existing legal authority to lower drug prices. Press release Letter
  • On April 26, Sen. Klobuchar (D-MN) and over 70 affordable health care groups held a press conference to advocate for Congress to take action on legislation to lower prescription drug prices. Press release
  • On April 28, Sens. Hassan (D-NH) and Braun (R-IN) sent a letter to the FDA Commissioner Califf urging the agency to update its policies for labelling opioid prescriptions. Press release Letter
  • Also on April 28, Sens. Manchin (D-WV) and Braun (R-IN) sent a letter to FDA Commissioner Califf urging him to implement recommendations from a report FDA Commissioner Califf requested during his previous tenure at FDA. These recommendations were meant to help the FDA re-examine its policies for addressing the drug epidemic. Press release Letter

Digital Health, Health IT and Privacy –

  • On April 25, HHS OIG released a report finding HHS’ information security program was ‘Not Effective’ and identified opportunities where HHS can strengthen its overall information security program. Overview Summary Report

Veteran Health and Military Health –

  • On April 25, the Department of Veterans Affairs (VA) announced it is adding nine rare respiratory cancers to the list of presumed service-connected disabilities due to military environmental exposures to fine particulate matter. Comments are due June 27, 2022. Press release Interim final rule
  • Also on April 25, VA OIG released an audit of the Electronic Health Record Modernization (EHRM) program master schedule, and found that the VA lacked a reliable integrated master schedule consistent with scheduling standards. Overview Report
  • Also on April 25, Sens. Blumenthal (D-CT) and Tester (D-MT) sent a letter to VA Secretary McDonough raising concerns about a proposed rule currently being considered by the VA, which would change the disability rating system for tinnitus, and urged the agency to refrain from adopting it. Press release Letter
  • On April 27, Sen. Crapo (R-ID) led an Idaho Congressional Delegation letter to VA Secretary McDonough expressing concerns with the VA’s prospective Electronic Health Record (EHR) system to be implemented at VA Medical Centers. Press release Letter
  • On April 28, GAO released a report about suicide prevention in remote installations and made 14 recommendations about how the DOD should enhance oversight, staffing, guidance, and training at remote installations. DOD recorded 384 active-duty servicemember suicides in 2020—an increase of 33.5 percent in the suicide rate since 2016. Overview Highlights Full report

Public Health and Health Equity–

  • On April 25, the Indian Health Service announced five million dollars in funding for “Ending the HIV Epidemic in the U.S.” to support work toward the elimination of HIV and hepatitis C in Indian Country. Press release
  • On April 28, CDC released a report finding the prevalence of hypertensive disorders in pregnancy among delivery hospitalizations increased from about 13 percent in 2017 to 16 percent in 2019, affecting at least 1 in 7 delivery hospitalizations during this period. Press release
  • Also on April 28, FDA announced that it will prohibit menthol flavored cigarettes and flavored cigars. Press release
  • On April 29, CDC released a request for nomination for the Community Preventative Services Task Force. Nominations are due by June 24, 2022. Federal register Request for nominations

Misc. –

  • On April 26, HHS released a report that provides welfare dependence indicators through 2019.

The dependency rate peaked in 2010 before declining from 5.3 percent in 2010 to 3.3 percent in 2019. Importantly, data from the report do not reflect the current economic recession resulting from the COVID-19 pandemic. Overview Report

  • On April 27, HHS announced a new Challenge competition inviting participants to develop innovative TeamSTEPPS video content, which is a training program to promote communication and teamwork between healthcare professionals. Submissions for phase one are due June 20, 2022. Press release Additional information
  • On April 28, Ways & Means Ranking Member Rep. Brady (R-TX) sent a letter to Ways & Means Chairman Neal (D-MA) outlining Republicans’ concerns with the Biden Administration’s proposed HHS budget. Press release Letter
  • On April 29, GAO released a report that made seven recommendations to CDC, FDA, NIH, and HHS to develop procedures for reporting and addressing allegations of political interference and train staff on how to report such allegations. Overview Report

Legislative Activity –

Votes and Committee Activity –

Introduced Legislation –

  • On April 26, Reps. Axne (D-IA) and Hudson (R-NC) introduced the Telehealth Extension and Evaluation Act (H.R. 7573), which would extend certain telehealth services covered by Medicare and evaluate the impact of telehealth services on Medicare beneficiaries. Press release
  • Also on April 26, Reps. Gallego (D-AZ) and Cole (R-OK) introduced the CDC Tribal Public Health Security and Preparedness Act (H.R. 7577), which would improve State, local, and Tribal public health security.
  • Also on April 26, Rep. Kelly (D-IL) and 59 cosponsors introduced the Health Equity and Accountability Act (H.R. 7585), which would improve the health of minority individuals. Press release
  • Also on April 26, Reps. Lesko (R-AZ), Miller-Meeks (R-IA), and Guthrie (R-KY) introduced the Securing the Border for Public Health Act of 2022 (H.R. 7586), which would provide for suspension of entries and imports from designated countries to prevent the spread of communicable diseases and import into the United States of certain controlled substances. Press release
  • Also on April 26, Rep. Takano (D-CA) introduced the Reduce and Eliminate Mental Health Outpatient Veteran (REMOVE) Copays Act (H.R. 7589), which would prohibit the imposition or collection of copayments for certain mental health outpatient care visits of veterans. Bill text Press release
  • Also on April 26, Reps. Tlaib (D-MI), Dingell (D-MI), Eshoo (D-CA), and Kelly (D-IL) introduced the Health Equity and Middle Eastern and North African (MENA) Community Inclusion Act of 2022 (H.R. 7591), which would amend the Public Health Service Act to include Middle Easterners and North Africans in the statutory definition of a racial and ethnic minority group. Bill text Press release
  • Also on April 26, Sen. Warnock (D-GA) and six cosponsors introduced the Medicaid Saves Lives Act (S. 2315), which would establish a program to provide health care coverage to low-income adults in States that have not expanded Medicaid.
  • Also on April 26, Sen. Cruz (R-TX) introduced the Protecting Americans from Unnecessary Spread upon Entry (PAUSE) from COVID–19 Act of 2022 (S. 4088), which would prohibit the Secretary of Health and Human Services from lessening the stringency of, and prohibit the Secretary of Homeland Security from ceasing or lessening implementation of, the COVID–19 border health provisions through the end of the COVID–19 pandemic.
  • Also on April 26, Sen. Durbin (D-IL) and Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022 (S. 4090), which would improve transparency and the availability of information regarding dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to list dietary supplements with the Food and Drug Administration. Press release
  • On April 27, Reps. McBath (D-GA), McClain (R-MI), Levin (D-MI), and Miller-Meeks (R-IA) introduced the Women, Infants, and Children (WIC) Healthy Beginnings Act of 2022 (H.R. 7603), which would establish a publicly available database of bid solicitations for infant formula under the special supplemental nutrition program for women, infants, and children. Press release
  • Also on April 27, Rep. Suozzi (D-NY) introduced the State Registries for Advance Directives Act (H.R. 7608), which would authorize the Secretary of Health and Human Services to award grants to States to develop, improve, or maintain a State registry of advance directives.
  • Also on April 27, Reps. Tiffany (R-WI) and Boebert (R-CO) introduced the Freedom to Fly Maskless (H.R. 7609), which would prohibit the appeal of the decision issued by the United States District Court for the Middle District of Florida determining that the mask mandate is unlawful. Bill text Press release
  • Also on April 27, Sens. Whitehouse (D-RI) and Cornyn (R-TX) introduced the Overdose Review Team Act (S. 4091), which would provide grants to States, units of local government, and Indian Tribes to establish, expand, or maintain Drug Overdose Fatality Review Teams. Bill text Press release
  • Also on April 27, Sens. Lujan (D-NM), Heinrich (D-NM), and Feinstein (D-CA) introduced the (S. 4096), which would require U.S. Customs and Border Protection to perform an initial health screening on all detainees.
  • Also on April 27, Sen. Warren (D-MA) and 6 cosponsors introduced the (S.4100), which would provide coverage under the Medicaid program for services provided by doulas and midwives.
  • On April 28, Reps. Blunt Rochester (D-DE), Fitzgerald (R-WI), and Wasserman Schultz (D-FL) introduced the (H.R. 7617), which would provide for a national public health education campaign, grant program, and task force for recommended preventive health care services during the COVID-19 pandemic and future pandemics.
  • Also on April 28, Reps. McCaul (R-TX), Speier (D-CA), Butterfield (D-NC), and Kelly (R-PA) introduced the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Reauthorization Act (H.R. 7630), which would maximize discovery, and accelerate development and availability, of promising childhood cancer treatments. Sens. Reed (D-RI), Capito (R-WV), Van Hollen (D-MD), and Murkowski (R-AK) introduced the companion legislation in the Senate (S. 4120). Press release
  • Also on April 28, Reps. McMorris Rodgers (R-WA), Banks (R-IN), Wenstrup (R-OH) and Burgess (R-TX) introduced the Protecting Health Care for All Patients Act (H.R. 7634), which would prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs. Press release
  • Also on April 28, Reps. Womack (R-AR) and 30 cosponsors introduced the Veterans First Act of 2022 (H.R. 7637), which would prohibit the use by the Department of Veterans Affairs of funds to provide emergency assistance at the southern border of the United States resulting from the repeal of certain public health orders. Sen. Boozman (R-AR) and 12 cosponsors introduced the companion legislation in the Senate (S. 4082) on April 26. Bill text Press release