Health Care Policy Update – Weekly Wrap-up and What’s Ahead – May 15, 2023


 

What’s Ahead: This Week
Hearings and Markups –
  • Tuesday, May 16
    • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Protecting Critical Infrastructure from Cyberattacks: Examining Expertise of Sector Specific Agencies.” Additional information
    • House Ways & Means Committee, “Health Care Price Transparency: A Patient’s Right to Know.” Additional information
    • Senate Homeland Security & Governmental Affairs Committee, “Artificial Intelligence in Government.” Additional information
    • Senate Judiciary Committee, Privacy, Technology, and the Law Subcommittee, “Oversight of A.I.: Rules for Artificial Intelligence.” Additional information
  • Wednesday, May 17
    • House Veterans’ Affairs Committee, Economic Opportunity Subcommittee, “The Transition Assistance Program: Steps to Ensure Success for Servicemembers as they Enter Civilian Life.” Additional information
    • House Ways & Means Committee, Health Subcommittee, “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets.” Additional information
    • Senate Finance Committee, Health Care Subcommittee, “Improving Health Care Access in Rural Communities: Obstacles and Opportunities.” Additional information
    • Senate HELP Committee, Primary Health and Retirement Security Subcommittee, “A Crisis in Mental Health and Substance Use Disorder Care: Closing Gaps in Access by Bringing Care and Prevention to Communities.” Additional information
    • Senate Veterans’ Affairs Committee, “Review of the FY2024 Budget and 2025 Advance Appropriations Requests for the Department of Veterans Affairs.” Additional information
  • Thursday, May 18
    • Senate Special Committee on Aging, “Residents at Risk: The Strained Nursing Home Inspection System and the Need to Improve Oversight, Transparency, and Accountability.” Additional information
Notable Policy Events – 
  • Tuesday, May 16 
    • National Institutes of Health (NIH), “7th Annual Vivian W. Pinn Symposium.” Additional information
    • Office of the National Coordinator for Health IT (ONC) Trusted Exchange Framework and Common Agreement (TEFCA) Recognized Coordinating Entity (RCE), “Monthly Informational Call.” Additional information
  • Wednesday, May 17 
    • Duke-Margolis Center for Health Policy, “2023 Health Policy Conference: Reversing the Slide in America’s Health.” Additional information
    • Health Affairs, “Policy Spotlight: One-on-One with Dawn O’Connell, Assistant Secretary for Preparedness and Response, US Department of Health and Human Services.” Additional information
    • Health Care Payment Learning & Action Center, “Health Equity: Partnering with Community-Based Organizations.” Additional information
    • ONC Health IT Advisory Committee (HITAC), “Monthly Committee Meeting.” Additional Information
  • Thursday, May 18 – Saturday, May 20 
Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare & Medicaid –
  • On May 9, CMS posted the 2023 Quality Measure Development Plan (MDP) Annual Report, which describes progress in developing clinician quality measures to support the Quality Payment Program. In Fiscal Year (FY) 2022, CMS developed eight measures and has three measures still in development in FY 2023. Report
  • Also on May 9, CMS released an update to its definition of a digital quality measure (dQM), which describes CMS’ goal for digital quality measurement and how dQMs contribute to a learning health system, among other areas. Additional Information
  • On May 10, CMS sent a notice to Medicare Advantage Organizations, Medicare Advantage Prescription Drug Plans and Prescription Drug Plan Sponsors notifying them that, beginning July 10, 2023, any material or activity that is distributed via any means that mentions any benefit will be considered marketing and must be submitted to the Health Plan Management System (HPMS). HPMS Memo
  • Also on May 10, HHS released resources on Medicaid unwinding of continuous coverage requirements enacted during the pandemic and returning to regular operations after the COVID-19 PHE ends. Resources
  • Also on May 10, the Senate Special Committee on Aging released state fact sheets on the consequences of Medicaid cuts. Press Release
  • On May 11, CMS released an Informational Bulletin with the updated 2023 Supplemental Security Income (SSI) and Spousal Impoverishment Standards. Bulletin
  • On May 12, CMS released a notice extending the approval of the Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) participation report, which is used to assess the effectiveness of state EPSDT programs in reaching eligible children by age group and basis of Medicaid eligibility. Comments are due June 14, 2023. Notice
  • Also on May 12, CMS released FAQs regarding changes made to the Medicaid continuous enrollment condition under the Families First Coronavirus Response Act (FFCRA) by the Consolidated Appropriations Act, 2023 (CAA, 2023). FAQs

Payment & Delivery System Models –

  • On May 8, CMS released the sixth annual report evaluating the Home Health Value-Based Purchasing (HHVBP) Model. This report focuses on the experience of home health patients and agencies through 2021. CMS Report
  • On May 11, the CMS Innovation Center released a blog post outlining progress to date on its health equity initiative, including promoting equitable care in new and existing models; increasing safety-net provider participation; and increasing collection and analysis of equity data. Blog
Public Health Preparedness, Prevention, Surveillance, & Data – 
  • COVID-19 Data: To date, there are 95,412,766 total COVID-19 cases and 1,047,741 COVID-19 deaths in the United States. Also, 984,444,295 COVID-19 vaccines have been delivered and 676,728,782 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 449 tests under Emergency Use Authorizations (EUAs), including 302 molecular tests, 83 antibody tests and 63 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On May 8, CMS released an informational bulletin regarding the end of the COVID-19 National Emergency on April 10, 2023, and the expected expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. Bulletin
  • On May 9, President Biden signed an Executive Order “Moving Beyond COVID-⁠19 Vaccination Requirements for Federal Workers,” which revokes the government-wide vaccination requirement for federal employees or federally specified safety protocols for federal contractors. Executive Order
  • Also on May 9, HHS released a fact sheet on the end of the COVID-19 PHE, with an update on current flexibilities enabled by the PHE and how they will be impacted by the end of the PHE on May 11. Fact Sheet
  • Also on May 9, President Biden signed a proclamation, “Revoking the Air Travel COVID-⁠19 Vaccination Requirement,” which would remove the international air travel restrictions imposed in October 2021. Proclamation
  • Also on May 9, the Biden Administration announced actions to ensure continued COVID-19 protections and surge preparedness after the PHE transition. Fact Sheet
  • On May 10, HHS Secretary Becerra sent a letter to U.S. Governors thanking them for their partnership during the COVID-19 PHE and expressing the importance of continuing access to COVID-19 vaccines, treatments, and tests. Letter
  • On May 11, the U.S. Government Accountability Office (GAO) released a report finding persistent deficiencies in HHS’ ability to lead and coordinate the nation’s preparedness for, and response to, PHEs. Report in Brief Report
  • Also on May 11, HHS Secretary Becerra released a statement on the end of the COVID-19 PHE, thanking the Biden Administration for its work during the COVID-19 pandemic. Press Release
  • On May 12, HHS Secretary Becerra signed the 11th amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for COVID-19 Medical Countermeasures. The amendment clarifies that COVID-19 continues to pose a credible risk of a future public health emergency, adds two new limitations on distribution, extends the time period of coverage for certain Covered Countermeasures and Covered Persons, clarifies the time period of coverage for Covered Persons authorized under the Declaration, and extends the duration of the Declaration to December 31, 2024. Notice
Health IT, Privacy, & Digital Health –
Mental Health and Substance Use Disorder Policy –
  • On May 9, FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA)  issued a joint letter to health care providers intended to clarify buprenorphine prescribing recommendations. The letter also affirmed both agencies’ commitment to addressing the overdose crises by reducing barriers to accessing evidence-based treatments and providing person-centered care for substance use disorders. Letter
  • On May 10, SAMHSA and the Drug Enforcement Agency (DEA) released a temporary rule to extend exceptions granted to existing DEA regulations from the COVID–19 PHE that allowed for the prescribing of controlled substances via telehealth without an in-person visit. The rule is effective May 11, 2023, through November 11, 2024. Rule SAMHSA Press Release DEA Press Release
  • Also on May 10, the White House convened state and local leaders for a forum on mental health and well-being during Mental Health Awareness Month. Press Release
  • On May 12, CDC released a report on emergency department visits involving mental health conditions, suicide-related behaviors, and drug overdoses among adolescents between January 2019 and February 2023. Report
Prescription Drugs, Medical Devices, & Biomedical Research & Health Innovation–
  • On May 10, FDA published a new web page with details about over-the-counter (OTC) Hearing Aids. Web Page
  • Also on May 10, FDA announced the availability of two discussion papers on artificial intelligence and machine learning in drug development and manufacturing. FDA also published a blog on the release of the two papers. Blog  Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products Artificial Intelligence in Drug Manufacturing
  • On May 11, FDA announced supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. Press Release
  • Also on May 11, GAO released a report on the 340B Drug Discount Program that allows certain hospitals to buy outpatient drugs at discounted prices. The Health Resources & Services Administration (HRSA) approved 53 of the 61 hospitals that requested an exception, as of May 31, 2022. This report includes information about how the agency managed the exception process and provides information on hospitals that received an exception. Report in Brief Report
  • Also on May 11, Senate Finance Committee Chair Wyden (D-OR) released a new Democratic staff memorandum with updated findings from his ongoing investigation into Big Pharma’s tax practices, finding that since 2017, Big Pharma’s average effective tax rate fell by more than 40 percent. Press Release Staff Memorandum
Veterans Health and Military Health –
  • On May 9, the Department of Veterans Affairs (VA) Office of Inspector General (OIG) released a report on the results of an evaluation of the inpatient and outpatient care provided at the Central Texas Veterans Health Care System. Report in Brief Report
  • Also on May 9, VA OIG released a report on its assessment of the effectiveness of VA’s controls over supplemental funds appropriated through the Coronavirus Aid, Relief, and Economic Security (CARES) Act to the Veterans Health Administration (VHA) to support VA’s efforts to prevent, prepare for, and respond to the COVID-19 pandemic. Report in Brief Report
  • Also on May 9, GAO published a study finding that VA organizational change management activities for the Electronic Health Record Modernization (EHRM) program were partially consistent with seven leading practices and not consistent with one leading practice. Report in Brief Report
  • On May 10, VA OIG released a report on its review of allegations that providers at the Charlie Norwood VA Medical Center delayed care and failed to “provide services,” for a patient who died by suicide on the grounds of the Aiken Community Based Outpatient Clinic. Report in Brief Report
  • On May 11, VA OIG released a report that determined that VA can improve its testing procedures and ensure adequate documentation is reviewed during payment testing for the Purchased Long-Term Services and Supports and Medical Care Contracts and Agreements programs. Report in Brief Report
  • Also on May 11, VA OIG released a report that describes the results of a focused evaluation of the outpatient settings at the West Texas VA Health Care System and associated outpatient clinics in Texas and New Mexico. Report in Brief Report
Population Health, Public Health & Health Equity –
  • On May 9, the U.S. Preventive Services Task Force (USPSTF) posted a draft recommendation that all women get screened for breast cancer every other year starting at age 40. Comments are due on June 5, 2023. Recommendation
  • On May 11, FDA released a guidance document for evaluating donor eligibility using individual risk-based questions to reduce the risk of HIV transmission by blood and blood products. The guidance loosens blood donation restrictions for men who have sex with men. Press Release Guidance Document
  • Also on May 11, HRSA submitted an information collection request on the Delta States Rural Development Network Grant Program. This program supports projects that demonstrate evidence-based and/or promising approaches around cardiovascular disease, diabetes, acute ischemic stroke, or obesity in order to improve health status in rural communities throughout the Delta Region. Notice Delta States Rural Development Network Program
Health Systems & Health Care Workforce –
  • On May 9, HRSA announced that health centers will submit aggregated Uniform Data System (UDS) data via HRSA’s Electronic Handbooks (EHBs) using the traditional submission method for 2023. Health centers that are ready to submit patient-level data (UDS+) are encouraged to do so. UDS Website
  • On May 10, the HHS Office for Civil Rights (OCR) released a press release announcing it settled a complaint with a Florida health center that failed to provide effective communication to a patient’s caregiver. Press Release
  • On May 11, the Department of Labor (DOL) announced the award of more than $78 million in grants to support workforce training programs in 17 states and address staffing challenges nursing professionals face in the care economy. Press Release
Reproductive, Maternal & Infant Health –
  • On May 8, the GAO released a report midwives, outlining information on midwife-attended births, midwifery workforce and midwifery education. The report outlined several challenges related to measuring the quality of maternal care, including difficulty attributing the quality of care to a specific provider because care is provided in teams and occurs over the course of pregnancy and delivery. Report in Brief Report
  • Also on May 8, Sens. Hyde-Smith (R-MS) and Lankford (R-OK) led letters to seven major U.S. pharmacies warning of federal and state laws, including longstanding federal laws that criminalize the mailing and interstate shipment of abortion drugs. Press Release Letters to CVS, Walgreens, and Rite Aid Letters to Walmart, Albertsons, Costco, and Kroger
  • On May 12, HHS celebrated the first anniversary of the National Maternal Mental Health Hotline and introduced an updated, more user-friendly toll-free number for the Hotline: 1-833-TLC-MAMA (1-833-852-6262). Press Release

Misc. –

  • On May 9, the HHS OIG published an audit finding that the HHS information security program was “Not Effective” based on HHS not meeting the “Managed and Measurable” maturity level for the Core Inspector General metrics in the function areas of Identify, Protect, Detect, Respond, and Recover. Report in Brief Report
  • On May 11, the White House released a statement highlighting progress on the first year of the Global Health Worker Initiative (GHWI). The U.S. is providing $10 billion in global health program funding to support the initiative. Statement
  • On May 12, the President proclaimed May 14 through May 20, 2023, as National Women’s Health Week. Proclamation

Legislative Activity –

Introduced Legislation –

  • On May 9, Sens. Grassley (R-IA), Feinstein (D-CA), and Hassan (D-NH) introduced the Stop Pills that Kill Act (S. 1475), which amends the Controlled Substances Act to prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances. Bill text Press release
  • Also on May 9, Sens. Gillibrand (D-NY), Marshall (R-KS), Feinstein (D-CA), Ernst (R-IA), and Casey (D-PA) introduced the National Task Force on the COVID-19 Pandemic Act (S. 1489), which establishes the National Task Force on the Response of the United States to the COVID-19 Pandemic. Bill text Press release
  • Also on May 9, Sen. Grassley (R-IA) and seven cosponsors introduced the Pharmacy and Medically Underserved Areas Enhancement Act (S. 1491), which provides for coverage under the Medicare program of pharmacist services. Bill text Press release
  • Also on May 9, Sen. Sinema (I-AZ) and Mullin (R-OK) introduced the 9-8-8 Lifeline Cybersecurity Responsibility Act (S. 1493), which secures the suicide prevention lifeline from cybersecurity incidents. Bill text Press release
  • Also on May 9, Sen. Smith (D-MN) introduced the Emergency Access to Insulin Act (S. 1497), which would establish insulin assistance programs. Press release
  • Also on May 9, Rep. Crockett (D-TX) and eight cosponsors introduced the Supporting All Healthy Options When Purchasing Produce (SHOPP) Act (H.R.3127), which would provide families year-round access to nutrition incentives, including hard-to-serve areas. Press release
  • Also on May 9, Rep. Sessions (R-TX) introduced the Health Care Fairness for All Act (H.R.3129), which would ensure health care fairness and affordability for all Americans through universal access to equitable health insurance tax credits, reformed health savings accounts, and strengthened consumer protections. Press release
  • Also on May 9, Reps. Chu (D-CA) and Fitzpatrick (R-PA) introduced the Acupuncture for Our Seniors Act of 2023 (H.R.3133), which would provide coverage for acupuncturist services under the Medicare program. Bill text Press release
  • Also on May 9, Reps. Craig (D-MN) and Phillips (D-MN) introduced the Emergency Access to Insulin Act (H.R.3134), which would establish insulin assistance programs. Press release
  • Also on May 9, Reps. Steil (R-WI) and Balint (D-VT) introduced the Protecting Young Minds Online Act (H.R.3164), which would direct the Center for Mental Health Services to develop and disseminate a strategy to address the effects of new technologies on children’s mental health. Press release
  • On May 10, Rep. Biggs (R-AZ) and 14 cosponsors introduced Veterans Health Care Freedom Act (H.R.3176), which would carry out a pilot program to improve the ability of veterans to access medical care in medical facilities of the Department of Veterans Affairs and in the community by providing the veterans the ability to choose health care providers. Sen. Blackburn (R-TN) introduced the companion legislation in the Senate (S.1545). Bill text Press release
  • Also on May 10, Sen. Scott (R-SC) introduced the Alan T. Shao II Fentanyl Public Health Emergency and Overdose Prevention Act (S.1532), which would suspend the entry of covered aliens in response to the fentanyl public health crisis. Press release
  • Also on May 10, Sens. Collins (R-ME), Coons (D-DE), Wicker (R-MS), and Durbin (D-IL) introduced the Reach Every Mother and Child (Reach) Act (S.1547), which would implement policies to end preventable maternal, newborn, and child deaths globally. Bill text Press release
  • Also on May 11, Rep. Eshoo (D-CA) and five cosponsors introduced the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act (H.R.3226), which would reauthorize the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act. Bill text Press release
  • Also on May 11, Reps. Estes (R-KS) and Connolly (D-VA) introduced the Ensuring Seniors’ Access to Quality Care Act (H.R.3227), which would allow nursing homes that have been forced to suspend in-house CNA education programs after receiving a certain level of penalties to resume those programs once quality standards are met. Bill text Press release
  • Also on May 11, Rep. Pressley (D-MA) and 25 cosponsors introduced the Targeting Resources for Equitable Access to Treatment for Long COVID (TREAT Long COVID) Act (H.R.3258), which would authorize the Secretary of Health and Human Services to award grants to eligible entities for creating or enhancing capacity to treat patients with Long COVID through a multidisciplinary approach. Bill text Press release
  • Also on May 11, Reps. Schiff (D-CA), Blunt Rochester (D-DE), and Barragan (D-CA) introduced the Support Faculty and Expand Access to Nursing School Act (H.R.3263), which would authorize grants to increase and support nurse faculty and clinical preceptors. Bill text Press release
  • Also on May 11, Rep. Smith (D-WA) introduced the Grant Assistance and Technical Education (GATE) Act (H.R.3268), which would establish within the Office of Minority Health, the position of Outreach Coordinator. Bill text Press release
  • Also on May 11, Sens. Hawley (R-MO) and Peters (D-MI) introduced Rural Hospital Cybersecurity Enhancement Act (S.1560), which would require the development of a comprehensive rural hospital cybersecurity workforce development strategy. Bill text Press release
  • Also on May 11, Sen. Blackburn (R-TN) and six cosponsors introduced the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act (S.1565), which would require Executive agencies to submit to Congress a study of the impacts of expanded telework and remote work by agency employees during the COVID-19 pandemic and a plan for the agency’s future use of telework and remote work. Bill text Press release
  • Also on May 11, Sens. Durbin (D-IL) and Lankford (R-OK) introduced the Rural Hospital Closure Relief Act (S.1571), which would restore State authority to waive for certain facilities the 35-mile rule for designating critical access hospitals under the Medicare program. Bill text Press release
  • Also on May 11, Sens. Stabenow (D-MI), Casey (D-PA), and Hassan (D-NH) introduced the Educating Future Nurses Act (S.1586), which would establish a national graduate nurse education program. Press release