What’s Ahead: This Week

Notable Policy Events –

  • Tuesday, July 5
    • American Academy of Actuaries, “Drivers of 2023 Health Insurance Premium Changes.” Additional information
  • Wednesday, July 6
    • The Heritage Foundation, “Scholars and Scribes Review the Rulings: The Supreme Court’s 2021-22 Term.” Additional information
  • Thursday, July 7
    • Johns Hopkins School of Advanced International Studies, “2021-2022 Supreme Court Term: Everything You Wanted to Know.” Additional information
  • Friday, July 8

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

Medicare, Medicaid & Marketplaces –

  • On June 27, HHS Secretary Becerra, Labor Secretary Walsh, and Treasury Secretary Yellen issued a letter to group health plans and health insurance issuers reminding them of their obligations under the ACA to provide coverage for contraceptive services at no cost. Plans and issuers are required to cover at least one form of contraception within each of the contraceptive categories identified by the FDA. Press Release Letter
  • Also on June 27, CMS released an update to the Medicaid and CHIP COVID-19 data snapshot, which includes data through January 2022. This snapshot provides information on COVID-19 related service utilization by beneficiaries including data on COVID-19 testing, treatment, and acute care use, service use among beneficiaries 18 years of age and younger, services delivered via telehealth, services for mental health and substance use disorders, and reproductive health services for female beneficiaries. Report
  • On June 28, the U.S. Government Accountability Office (GAO) issued a report on state directed payments in Medicaid managed care. In this report, GAO describes (1) the use of state directed payments in Medicaid, and (2) CMS’s changes to guidance and oversight of these payments. Although CMS has recently made efforts to enhance oversight, the effectiveness of these efforts is unknown and information gaps remain.  Report in Brief Report
  • Also on June 28, GAO issued testimony before the House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, with recommendations for the continued monitoring and implementation of Medicare Advantage plans. Testimony
  • Also on June 28, CMS approved an extension of Vermont’s Medicaid section 1115 demonstration, “Global Commitment to Health.” This extension will enable the state to continue to test, monitor, and evaluate a managed care-like delivery system, home and community-based services, and novel pilot programs, as well as pursue innovations to maintain high-quality services and programs that are cost-effective. Press Release
  • On June 29, CMS issued updates to guidance on minimum health and safety standards that Long-Term Care (LTC) facilities musty meet to participate in Medicare and Medicaid. CMS also updated and developed new guidance in the State Operations Manual (SOM) to address issues that significantly affect residents of LTC facilities. CMS also issued surveyor guidance which clarifies specific regulatory requirements and provides information on how compliance will be assessed. Press Release Fact Sheet
  • Also on June 29, CMS released the latest enrollment figures for Medicare, Medicaid, and CHIP. Enrollment Data
  • On June 30, CMS released newly updated Coverage to Care (C2C) resources to help those served by CMS understand their health coverage and get health care services they need. Updated resources include the Roadmap to Better Care, Roadmap to Behavioral Health, Prevention Flyers, and more. These updated materials are available in both English and Spanish. Announcement
  • Also on June 30, CMS released a proposed rule establishing conditions of participation (CoPs) that Rural Emergency Hospitals (REH) must meet to participate in the Medicare and Medicaid programs, and modifying certain CoPs for Critical Access Hospitals. The rule seeks to ensure the health and safety of patients who will receive REH services in the most efficient manner possible, while taking into consideration the access and quality of care needs of an REH’s patient population. CMS is seeking input from the rural community on specific proposed REH standards. Comments are due by August 29, 2022. Press Release Fact Sheet Proposed Rule
  • Also on June 30, CMS published Program Year (PY) 2021 Open Payments (PY) data that publicly disclose the financial relationships between applicable manufacturers and group purchasing organizations and certain health care providers. This data publication reflects a total of 12.1 million records and $10.9 billion in publishable payments or transfers of value made to covered health care providers during PY 2021. Press Release
  • Also on June 30, Sen. Shaheen (D-NH) led a group of Senators on a letter to Senate Majority Leader Schumer (D-NY) and House Speaker Pelosi (D-CA), urging congressional leadership to prioritize making permanent the ACA enhanced premium tax credits in upcoming reconciliation legislation, which are set to expire at the end of this year. Press Release Letter

Payment & Delivery System Models –

  • On June 27, CMS announced the new, voluntary Enhancing Oncology Model (EOM). Oncology practices that participate in EOM will take on financial and performance accountability for episodes of care surrounding systemic chemotherapy administration to patients with common cancer types. EOM is set to launch on July 1, 2023 and will be a five-year model test. The application period for EOM is currently open through September 30, 2022.  Press Release Fact Sheet Request for Applications
  • On June 30, CMS announced selected participants for the revamped Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model. Announcement

Public Health & Prevention –

  • Data: To date, there are 87,407,521 total COVID-19 cases and 1,013,261 COVID-19 deaths in the United States. Also, 770,337,705 COVID-19 vaccines have been delivered and 596,233,489 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.
  • On June 28, HHS and FDA announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Press Release Fact Sheet
  • Also on June 28, CDC activated the Emergency Operations Center (EOC) for monkeypox response. This action stands up the CDC’s command center for monitoring and coordinating the emergency response to monkeypox and mobilizing additional CDC personnel and resources, and will allow CDC to further increase operational support for the response to meet the outbreak’s evolving challenges. Media Statement
  • Also on June 28, the Biden-Harris Administration announced the first phase of its national monkeypox vaccine strategy. The vaccine strategy will help immediately address the spread of the virus by providing vaccines across the country to individuals at high risk. This phase of the strategy aims to rapidly deploy vaccines in the most affected communities and mitigate the spread of the disease. Fact Sheet
  • Also on June 28, HHS announced an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox. The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aide their planning and response efforts. Press Release
  • On June 29, HHS, in collaboration with the Department of Defense (DoD), announced an agreement to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options for up to 300 million doses. Press Release
  • On June 30, FDA’s independent experts on the Vaccines and Related Biological Products Advisory Committee met to discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons; an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022. Press Release
  • On July 1, HHS ordered an additional 2.5 million doses of Bavarian Nordic’s JYNNEOS, an FDA-licensed vaccine indicated for prevention of smallpox and monkeypox, for use in responding to current or future monkeypox outbreaks and as part of U.S. smallpox preparedness. Deliveries from this latest order will begin arriving at the Strategic National Stockpile (SNS) later this year and will continue through early 2023. Press Release
  • Also on July 1, HHS began delivering additional doses of vaccine as part of an enhanced nationwide strategy to mitigate the spread of monkeypox in communities where transmission is highest and with populations most at risk. Press Release

Health IT, Privacy & Digital Health –

  • On June 27, GAO issued a report on electronic health information and covered entities’ required reporting to HHS on data breaches. This report examines (1) the number of breaches and affected individuals reported to HHS since 2015; (2) the extent to which HHS established a review process to assess whether covered entities had implemented recognized security practices; and (3) the extent to which improvements can be made related to HHS’s breach reporting requirements. Report
  • Also on June 27, HHS issued a report on Linking State Health Care Data to Inform Policymaking: Opportunities and Challenges, which provides additional detail on current All Payer Claims Database (APCD) data collection and data access procedures, describes additional use cases, and discusses some of the most important challenges associated with operating an APCD or working with APCD data. Press Release Report
  • On June 28, the Office of the National Coordinator for Health IT (ONC) announced the publication of the Approved Standards for 2022 as part of the annual Standards Version Advancement Process (SVAP). Fact Sheet Blog
  • On June 29, HHS issued new guidance to help protect data privacy for patients seeking reproductive health care, as well as their providers. The guidance: (1) addresses how federal law and regulations protect individuals’ private medical information; and (2) addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps. Press Release
  • On June 30, ONC published a blog on key themes from ONC’s Health Information Technology Advisory Committee (HITAC) hearing in March 2022, which include: consistent, equitable data collection and interoperability challenges; the digital divide; and artificial intelligence considerations, including transparency and the importance of identifying bias and curtailing its impacts. Blog
  • Also on June 30, Senate Aging Committee Chairman Casey (D-PA) led a bipartisan group of Senators in sending a letter to Attorney General Merrick Garland demanding information on web accessibility for people with disabilities across the federal government. Press Release

Mental Health and Substance Use Disorder Policy –

  • On June 27, the Substance Abuse and Mental Health Services Administration (SAMHSA) recognized National HIV Testing Day (NHTD) as an opportunity to emphasize and encourage HIV testing. Press Release
  • Also on June 27, SAMHSA recognized June as posttraumatic stress disorder month and offered information on symptoms as well as treatment and support options. Press Release
  • On June 29, the Department of Justice (DOJ) announced the formation of the New England Prescription Opioid (NEPO) Strike Force, a joint law enforcement effort that seeks to identify and investigate health care fraud schemes in the New England region, and to effectively and efficiently prosecute individuals involved in the illegal distribution of prescription opioids and other prescribed controlled substances. Press Release

Prescription Drugs, Medical Devices, & Biomedical Research –

  • On June 27, the FDA released a proposed rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” which seeks to expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use. Comments are due by October 26, 2022. Press Release Proposed Rule
  • On June 28, OIG released a report examining the extent to which formularies used by Medicare Part D plans include prescription drugs commonly used by dual eligible individuals. The report found that dual eligible individuals have access to most of the commonly used prescription drugs in 2022 via Part D plans. Report in Brief Report
  • On June 30, Sens. Duckworth (D-IL) and Durbin (D-IL) led members of the Illinois Congressional Delegation in a letter to HHS Secretary Becerra and Acting Deputy Director Adam Russell, requesting that the new medical research agency, Advanced Research Projects Agency for Health (ARPA-H) be headquartered in the Chicago, IL area, based on its geographical location, array of jobs, companies, students, and professionals in life sciences and various local stakeholders’ commitment to health equity. Press Release Letter
  • On July 1, HHS released a report describing how price indices are used to compare prescription drug prices between countries, finding that the magnitude of difference between prices in the United States and those in other countries was substantial. For all drugs, U.S. prices were 256 percent of prices in other countries, among other findings. Report in Brief Report

Veterans Health & Military Health  –

  • On June 28, the Veterans Affairs (VA) Office of Inspector General (OIG) conducted a health care inspection to assess concerns regarding facility providers’ failures to communicate, act on, and document a patient’s abnormal test results for patients with metastatic prostate cancer. The OIG concluded that the failures to communicate, act on, and document abnormal test results contributed to a delay in the diagnosis of prostate cancer. Press Release
  • Also on June 28, the VA OIG conducted a review to determine whether VA complied with the requirements of the Payment Integrity Information Act of 2019 (PIIA) for fiscal year 2021, finding that VA failed to report an improper and unknown payment rate of less than 10 percent for four VA programs and activities that had estimates in the accompanying materials to their financial statements. Press Release
  • On June 29, GAO issued a report examining the DOD offerings to eligible military families of several services to support caregivers of special needs dependents. GAO made two recommendations to DOD: (1) to communicate in writing that there is no TRICARE requirement for another adult to remain in the home during the provision of ECHO respite care; and (2) to collect and analyze data regarding the utilization of ECHO respite care. DOD concurred with both recommendations. Report in Brief Report
  • On June 30, the VA OIG assessed allegations at the New Mexico VA Health Care System regarding the policy and practices related to the provision of buprenorphine treatment for patients with opioid use disorder. The OIG found that pharmacists declined early refills of buprenorphine despite prescribing providers documented clinical rationales and that the Opioid Safety Committee pharmacist placed standing orders for urine drug screening without coordinating with patients’ prescribing providers. Press Release
  • Also on June 30, the VA OIG conducted an audit to determine if VA medical facilities met requirements to safeguard the potency and value of refrigerated pharmaceuticals. The OIG found that VA medical facilities generally stored pharmaceuticals within manufacturer-recommended temperature ranges to maintain potency. Press Release
  • Also on June 30, the VA published its first of 50 draft national standards of practice, which enables the VA to move health care professionals seamlessly throughout the organization. Further, national standards will support VA health care professionals practicing across state lines and creates standardized practice and business operations across VA medical facilities. Press Release
  • On July 1, Senate Veterans’ Affairs Committee Chairman Tester (D-MT) and Ranking Member Moran (R-KS) led a letter to VA Secretary McDonough and Office of Personnel Management Director Ahuja urging the Biden-Harris Administration to streamline hiring of mental health care professionals to fill critical mental health vacancies as directed under the Commander John Scott Hannon Veterans Mental Health Care Improvement Act. Press Release Letter
  • Also on July 1, the VA implemented a final rule describing the authority to provide support for donation procedures and related care to those who donate an organ or bone marrow to Veterans for transplants. Press Release Final Rule

Health Systems, Public Health & Health Equity –

  • On June 27, HHS released a request for information as part of its Initiative to Strengthen Primary Health Care. The goal of the initiative is to develop a federal foundation for the provision of primary health care for all that supports improved health outcomes and advanced health equity. The first step is to produce an initial HHS Action Plan in 2022. Comments are due by August 1, 2022. Fact Sheet  Request for Information
  • On June 30, the White House issued a fact sheet on health sector leaders joining the Biden Administration in its pledge to reduce greenhouse gas emissions by 50 percent by 2023. The pledge was signed by 61 organizations, leading health sector suppliers, and major medical associations. Fact Sheet
  • Also on June 30, HHS issued a press release outlining private health sector commitments to reduce climate impacts and protect public health. Press Release
  • Also on June 30, HHS Secretary Becerra issued a statement in response to the U.S. Supreme Court decision in the case of West Virginia v. EPA expressing concern for the wide-ranging impacts carbon emissions can have on public and individual health. Press Release
  • On July 1, HHS announced over $155 million in awards for 72 teaching health centers that operate primary care medical and dental residency programs that include high need specialties such as psychiatry, as part of President Biden’s Unity Agenda to address the nation’s mental health crisis. Press Release

Maternal & Reproductive Health –

  • On June 28, HHS Secretary Becerra gave remarks at a press conference in response to President Biden’s directive following the overturning of Roe v Wade. Remarks
  • On June 29, HHS launched a new website, reproductiverights.gov, to provide information on access to and coverage of reproductive health care and resources. Website
  • On June 30, HHS approved Washington state’s extension of Medicaid and CHIP coverage for 12 months after pregnancy. As a result, up to an additional 12,000 people annually will now have access to Medicaid or CHIP coverage for a full year after pregnancy. With this approval, an estimated 265,000 Americans annually in 15 states and D.C. have gained access to 12 months of postpartum coverage. Press Release
  • Also on June 30, HHS Secretary Becerra convened a virtual roundtable with Governors to discuss the recent Dobbs v. Jackson Women’s Health Organization Supreme Court ruling, reiterate HHS’ commitment to reproductive health care access, and listen to any state-specific concerns. Participants included Michigan Governor Gretchen Whitmer, Oregon Governor Kate Brown, and Maine Governor Janet Mills. Press Release
  • Also on June 30, HHS announced nearly $3 million in new funding to bolster training and technical assistance for the nationwide network of Title X family planning providers. Press Release

Infant Formula –

  • On June 27, 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 696 million cans (about 1.4 million pounds or about 21 million full-size, eight-ounce bottles) of Bellamy’s Organic Infant Formula Step 1 (0-6 months) and Bellamy’s Organic Follow-On Formula Step 2 (6-12 months) have been imported into the US. Press Release
  • On June 28, 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 18,677 cans (about 35,000 pounds or about 535,000 full-size, eight-ounce bottles) of Similac Advance 2’-FL Stage 1 have been imported into the US. Press Release
  • On June 30, President Biden announced the eleventh Operation Fly Formula mission. This flight will transport Nestlé infant formula from Australia to Fort Worth, TX on July 4. This delivery will include over 56,000 pounds of Nestlé NAN SensiPro formula, the equivalent of approximately 849,000 eight-ounce bottles. The product will be available through Gerber.com. Press Release
  • Also on June 30, President Biden announced the twelfth Operation Fly Formula mission. This flight will transport Danone’s Nutricia specialized medical formulas from Europe to New York, NY and Chicago, IL on July 8 and will include a total of approximately 190,000 pounds of Neocate Junior and Neocate Infant DHA/ARA, the equivalent of approximately two million eight-ounce bottles. Press Release
  • On July 1, President Biden announced the thirteenth Operation Fly Formula mission. This flight will transport Reckitt Mead Johnson infant formula base powder from Singapore to Chicago, IL on July 12, 14, and 19, which will include over 418,000 pounds of Reckitt Mead Johnson Enfamil Stage 1 infant formula base (the equivalent of 6.2 million eight-ounce bottles). Press Release

Legislative Activity –
Votes and Committee Activity –

  • On June 29, the House Appropriations Committee approved the fiscal year 2023 Labor, Health and Human Services, Education, and Related Agencies appropriations bill on a 32 to 24 vote. The bill provides $242.1 billion, an increase of $28.5 billion – 13 percent – above 2022. Summary Draft Text  Bill before adoption of amendments Press Release Report

Introduced Legislation –

  • On June 27, Rep. Bishop (D-GA) introduced the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 (H.R. 8239), which provides FY2023 appropriations for the Department of Agriculture (USDA), the Food and Drug Administration, and related agencies. Press Release

On June 28, Reps. Van Drew (R-NJ) and Harris (R-MD) introduced the No Patient Left Alone Act (H.R. 8252), which would codify patients’ rights to hospital visitation. Bill Text Press Release