Health Care Policy Update – Weekly Wrap-up and What’s Ahead – July 11, 2022


What’s Ahead: This Week

Hearings & Markups –

  • Monday, July 11
    • House Veterans Affairs Committee, “Hearing on Ending Veteran Hunger: Examining the Impact of COVID-19 on Food Insecurity.” Additional information
  • Tuesday, July 12
    • Senate Finance Committee, “Hearing to Consider the Nominations of Jay Curtis Shambaugh, of Maryland, to be an Under Secretary of the Treasury and Rebecca Lee Haffajee, of Massachusetts, to be an Assistant Secretary of Health and Human Services.” Additional information
    • Senate Judiciary Committee, “A Post-Roe America: The Legal Consequences of the Dobbs Decision.” Additional information
    • House Committee on Rules, “Meeting Announcement for Markup on Women’s Health Protection Act and Ensuring Access to Abortion Act.” Additional information
  • Wednesday, July 13
    • Senate HELP Committee, “Hearing on Reproductive Care in A Post-Roe America, Focusing on Barriers, Challenges, And Threats to Women’s Health.” Additional information
  • Thursday, July 14
    • House Veterans Affairs Committee, Subcommittee on Health, “Hearing on Examining VA Community Care Access, Utilization, and Expenditures.” Additional information

Notable Policy Events –

  • Monday, July 11
  • Tuesday, July 12 – Wednesday, July 13
  • Tuesday, July 12
  • Wednesday, July 13
    • Congressional Social Determinants of Health Caucus, “Briefing: Addressing Food Insecurity and Nutrition as a Social Determinant of Health.” Additional information
    • Congressional Diabetes Caucus and Diabetes Advocacy Alliance, “A Call to Action: Rising to Meet the Challenge of the Diabetes Epidemic.” Additional information
    • Health Care Transformation Task Force, “Population Health Indices to Support Health Equity Integration.” Additional information
    • Centers for Medicare and Medicaid Services, “National Nursing Home Stakeholder Call.” Additional information
  • Thursday, July 14
    • Bipartisan Policy Center and Tufts University, “National Convening to Inform the White House Conference on Hunger, Nutrition, and Health.” Additional information
  • Friday, July 15
    • Brookings Institute, “Revising Payment to Medicare Advantage Plans to Reflect the Rapid Growth in Enrollment.” Additional information
    • Alliance for Health Policy, “The Effects of Expiring Pandemic Relief Measures on Coverage and Affordability: A Future Look”. Additional information

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

Medicare, Medicaid & Marketplaces –

  • On July 5, HHS Office of Inspector General (OIG) published a report assessing the financial impact that Medicare’s transfer policy and reduced outlier threshold have on Medicare total payments for transfer claims compared with what hospitals would have been paid if the beneficiary had been discharged instead of transferred. The report concluded that Medicare’s reduced outlier threshold for transfer claims does not have a significant enough impact to recommend a policy change. Report in Brief Report
  • On July 6, CMS unveiled a suite of new resources to improve CMS and state oversight of Medicaid and CHIP managed care programs, which includes tools, templates, and updates on tactics to improve states reporting on their managed care programs. Press Release Informational Bulletin
  • On July 7, CMS issued the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) proposed rule and accompanying fact sheets. This proposed rule would significantly expand access to behavioral health services, Accountable Care Organizations (ACOs), cancer screening, and dental care, and proposes changes to the Medicare Shared Savings Program (MSSP) to advance CMS’ overall value-based care strategy of growth, alignment, and equity, among other key proposals. Proposed Rule Press Release MSSP Fact Sheet  General Fact Sheet QPP Fact Sheet  Behavioral Health Blog
  • On July 8, HHS published a research brief focusing on change of ownership transactions for skilled nursing facilities (SNFs). The brief analyzes variation by geographic location and quality of nursing homes being sold. Research Brief

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 438 tests under Emergency Use Authorizations (EUAs), including 303 molecular tests, 85 antibody tests and 49 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On July 6, the FDA revised the Emergency Use Authorization(EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible COVID-19 patients. Press Release
  • Also on July 6, the CDC announced that Labcorp will begin testing for monkeypox using CDC’s orthopoxvirus test. This test detects all non-smallpox related orthopoxviruses, including monkeypox. Press Release
  • On July 7, HHS announced that it will make an additional 144,000 doses of the JYNNEOS vaccine available to states and jurisdictions, as part of the Biden Administration’s strategy to combat monkeypox.  These doses of JYNNEOS vaccine will begin shipping from the Strategic National Stockpile (SNS) on July 11. Press Release

 

Health IT, Privacy, & Digital Health –

 

  • On July 6, the FDA published draft guidance for industry entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.” This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. Guidance Document Notice
  • On July 7, ONC approved the Drummond Group’s Drummond G10+ FHIR API powered by Touchstonetool, a new alternative test method (ATM) for testing conformance to ONC’s 170.315(g)(10) Standardized API for patient and population services certification criterion. Announcement
  • On July 8, House Oversight and Reform Committee Chair Maloney (D-NY), Subcommittee on Economic and Consumer Policy Chair Krishnamoorthi (D-IL), and Rep. Sara Jacobs (D-CA) sent letters to five data broker companies and five personal health application companies requesting information and documents regarding the collection and sale of personal reproductive health data and expressing concerns about misuse of this data to invade privacy of individuals seeking reproductive health care. Press Release

Mental Health and Substance Use Disorder Policy –

  • On July 8, SAMHSA published a notice requesting approval for its “Talk. They Hear You.” media campaign’s “Screen 4 Success” Consent Form and Screener. The campaign aims to reduce underage drinking and substance use among youths under the age of 21 by providing parents and caregivers with information and resources they need to address alcohol and other drug use with their children early. Notice

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On July 6, the FDA issued a notice requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. Notice
  • Also on July 6, the FDA published revised draft guidance for industry entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act. The guidance will assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the DSCSA. Comments will be accepted through September 6, 2022. Guidance Document Notice
  • Also on July 6, HHS published research in the Journal of the American Medical Association (JAMA) Open Network that showed antibiotic prescribing at ambulatory care clinics was cut almost in half in clinics that participated in a safety program funded by HHS’ Agency for Healthcare Research and Quality (AHRQ). Press Release
  • On July 7, Senate Finance Committee Chair Wyden (D-OR) released an interim report in his investigation into “Big Pharma’s” tax practices. Press Release
  • Also on July 7, Senators Toomey (R-PA), Barrasso (R-WY), Portman (R-OH), Sasse (R-NE), and Daines (R-MT) called on Senate Finance Committee Chairman Wyden (D-OR) and Ranking Member Crapo (R-ID) to ensure proper committee process for the consideration of Senators Shaheen (D-NH) and Collins’ (R-ME) insulin proposal. Press Release Letter

Veterans Health and Military Health  –

  • On July 7, the VA released a final rule amending its regulations concerning the standards of ethical conduct and related responsibilities of its employees by adopting an overarching principle-based ethics framework for access to and use of veteran data. The intent of the framework is to ensure uniform ethics standards for data practices and address consumer protection and data stewardship concerns that are beyond traditional privacy and confidentiality practices. Final Rule
  • Also on July 7, the VA OIG released a report based on a review to identify clinical and non-clinical occupations experiencing staffing shortages within the VA. The OIG found that all 139 VA facilities reported at least one severe occupational staffing shortage. Report in Brief Report

Health Systems, Public Health & Health Equity –

  • On July 5, CMS published a review examining three CMS Innovation Center models to identify potential sources of bias, and found that use of certain risk-assessment and screening tools, provider tools, and payment design and risk-adjustment algorithms has led to the exclusion of some beneficiaries from these models. CMS has taken initial actions to address these sources of bias for ongoing models. Report in Brief Report
  • Also on July 5, U.S. Surgeon General Dr. Vivek Murthy launched the inaugural episode of his new podcast, House Calls with Dr. Vivek Murthy. The podcast will highlight the vital need for people to build connections with one another, not just for individual health and wellbeing, but for our collective recovery as a nation. Press Release Podcast
  • On July 8, CMS published a blog outlining recent work to advance health equity through the release of the CMS Framework for Health Equity. Outlining five priority areas, the Framework updates the 2015 Medicare-focused CMS Equity Plan for Improving Quality in Medicare with an enhanced and more comprehensive 10-year plan to further embed health equity across all CMS programs and the Marketplace. Blog

 

Maternal Health

  • On July 5, U.S. Surgeon General Dr. Murthy issued a statement on the Supreme Court’s ruling on Dobbs v. Jackson, overturning Roe v. Wade. Remarks
  • Also on July 5, Senator Rubio (R-FL) sent a letter to Office of Personnel Management (OPM) Director Kiran Ahuja urging the Biden Administration to address potential Hyde Amendment violations regarding abortion travel. Press Release Letter
  • On July 6, the CDC published a report presenting trends in primary and repeat cesarean delivery from 2016 to 2021 and recent changes in these rates by maternal age, race and Hispanic origin, gestational age, and state of residence from 2019 to 2021. Between 2016 and 2019, the primary cesarean delivery rate generally declined before increasing one percent in 2020 and two percent in 2021. In contrast, the repeat cesarean delivery rate decreased every year during this period, resulting in a two percent total decline. Report
  • On July 8, President Biden signed an Executive Order on Protecting Access to Reproductive Health Care Services. This Executive Order defends reproductive rights by: (1) Safeguarding access to reproductive health care services, including abortion and contraception; (2) Protecting the privacy of patients and their access to accurate information; (3) Promoting the safety and security of patients, providers, and clinics; and (4) Coordinating the implementation of Federal efforts to protect reproductive rights and access to health care. Executive Order Fact Sheet

Infant Formula –

  • On July 5, HHS announced two Operation Fly Formula flights currently scheduled for the week of July 4, projected to import approximately 3.2 million eight-ounce bottle equivalents of infant formula to the United States. By July 10, Operation Fly Formula flights will have completed 39 flights and imported more than 43 million eight-ounce bottle equivalents of infant formula. Press Release
  • On July 6, 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 3,192 cans (about 2,815 pounds or about 39,844 full-size, eight-ounce bottles) of Vitaflo USA LLC’s PKU Start formula have been imported into the US. The product will be available within two weeks through direct purchase from Vitaflo and medical distribution channels, with a second round of product expected to be available in September. Press Release
  • Also on July 6, the FDA announced the success of its flexibilities that have enabled the agency to dramatically increase infant formula supplies to address the shortage, while also protecting the health of infants. Given this success, the FDA is developing a new framework for continued, expanded access to infant formula options for parents and caregivers. Press Release
  • Also on July 6, President Biden announced the fourteenth Operation Fly Formula mission to transport Bubs Australia infant formula from Australia to Ontario, CA and Columbus, OH via flights on July 10 and 21 respectively. Press Release
  • Also on July 6, President Biden announced the fifteenth Operation Fly Formula mission to transport Kendamil baby formula from England to New York, NY via flights on July 17 and 22. Press Release
  • On July 8, President Biden announced the sixteenth Operation Fly Formula mission to transport Nestlé Health Science amino acid-based formula from Switzerland to John F. Kennedy Airport in New York, NY on July 10 and 11. Press Release

Misc. –

  • On July 5, HHS and DOJ released an annual report on the Health Care Fraud and Abuse Control Program (HCFAC) for Fiscal Year (FY) 2021. During 2021, the federal government won or negotiated more than $5 billion in health care fraud judgments and settlements, in addition to other health care administrative impositions. Because of these efforts, almost $1.9 billion was returned to the federal government or paid to private persons in FY21. Report in Brief Report

Legislative Activity –

Votes and Committee Activity –

  • On July 6, the Senate Finance Committee released updated drug pricing legislation that would cap Medicare Part D beneficiary spending before the next presidential election and eliminate monthly insulin copay caps that were in the previous version of the legislation. On July 8, CBO released an analysis estimating that the legislation would reduce federal spending by $288B over ten years.  Full Text CBO Analysis

Introduced Legislation –

  • On July 5, Reps. Spanberger (D-VA), Wild (D-PA), Porter (D-CA), Craig (D-MN), and Axne (D-IA) introduced the Banning Misleading Drug Ads Act (H.R. 8289), which would promulgate a past due final rule with respect to direct-to-consumer prescription drug advertisements. Bill text Press release
  • On July 7, Reps. Chu (D-CA), Pressley (D-MA), Frankel (D-FL), and Escobar (D-TX) introduced the Women’s Health Protection Act of 2022 (H.R. 8296), which would protect a person’s ability to determine whether to continue or end a pregnancy, and protect a health care provider’s ability to provide abortion services. Bill text Press release
  • Also on July 7, Reps. Fletcher (D-TX), Strickland (D-WA), and Raskin (D-MD) introduced the Ensuring Access to Abortion Act of 2022 (H.R. 8297), which would prohibit the interference, under color of State law, with the provision of interstate abortion services. Bill text Press release
  • Also on July 7, Reps. Jacobs (R-NY) and Bacon (R-NE) introduced legislation (H.R. 8307), which would require certain medical information related to donors of reproductive tissue be made available to recipients of such tissue and persons conceived using such tissue. Bill text