The following is the latest health policy news from the federal government for the week of September 19-27. Some of the language used below is taken directly from government documents.
The White House has issued a fact sheet summarizing new actions and funding to address the overdose epidemic and support recovery as part of its September “National Recovery Month.”
- Awarding $1.5 billion for all states and territories to address addiction and the opioid crisis.
- Investing more than $104 million to expand substance use treatment and prevention in rural communities.
- Investing $20.5 million to increase access to recovery supports.
- Releasing new guidance to support and facilitate greater access to FDA-approved naloxone products.
- Announcing additional funding for law enforcement officials on the front lines of the overdose epidemic.
- Releasing new guidance for employers to create recovery-ready workplaces.
- Deploying financial sanctions to disrupt global drug trafficking operations.
Learn more about these efforts and find a list of state opioid response grant awards from this administration fact sheet. Some of these initiatives are described in greater detail below.
Department of Health and Human Services
- Providers that received one or more general or targeted payments exceeding $10,000 in aggregate from the COVID-19 Provider Relief Fund must submit financial data through the Provider Relief Fund reporting portal for reporting period 3 by September 30. Go here for more information on the requirements and how to submit reports.
- HHS has purchased 60,000 doses of the monoclonal antibody bebtelovimab, which is used to treat COVID-19. Now, providers that use a commercially procured dose of bebtelovimab for uninsured or underinsured patients may be eligible to have the dose replaced for free by HHS. At the current rate of use, the additional doses purchased for this initiative are expected to be available through September 2023. Learn more about the program from this HHS news release.
- As noted above, HHS, its Substance Abuse and Mental Health Services Administration (SAMHSA), and the Health Resources and Services Administration (HRSA) have awarded more than $1.6 billion to programs in communities throughout the country that address the addiction and overdose crises. The awards encompass four types of funding:
- SAMHSA’s State Opioid Response grant program, which provides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of opioid use disorder and for supporting prevention, harm reduction, treatment, and recovery support services for opioid use disorder and other concurrent substance use disorders.
- SAMHSA’s Tribal Opioid Response program, which addresses the overdose crisis in Tribal communities by increasing access to FDA-approved medications for the treatment of opioid misuse and supporting prevention, harm reduction, treatment, and recovery support services for opioid and stimulant misuse and co-occurring mental and substance use conditions.
- Funding to states to support the State Opioid Response and Tribal Opioid Response programs.
- HRSA’s Rural Communities Opioid Response Program, for purposes described separately below.
Learn more about the funding and these initiatives from this HHS news release.
- As noted above, HHS and HRSA have awarded more than $104 million to expand treatment and prevention services for substance use in rural communities nationwide as part of the Rural Communities Opioid Response Program. The awards were made in three categories:
- Rural Communities Opioid Response Program – Medication Assisted Treatment Access – $10 million to establish new medication-assisted treatment access points for substance use disorder, including opioid use disorder.
- Rural Communities Opioid Response Program – Implementation – $65 million to strengthen and expand opioid use disorder prevention, treatment, and recovery services in rural communities using workforce development and training, telehealth, health care integration, and family support services.
- Rural Communities Opioid Response Program – Behavioral Health Care Support – $29 million to improve the quality and sustainability of behavioral health care services in rural communities.
Learn more from this HRSA news release.
- HHS and HRSA have awarded more than $5 million to 11 HRSA-funded community health centers to facilitate access to cancer screenings and early detection services for underserved populations. These partnerships are bringing health centers together with National Cancer Institute-Designated Cancer Centers. Learn more about this program and find a list of grant recipients from this HHS news release.
- HHS’s Office on Women’s Health has awarded nearly $1 million in grants to improve early detection and prevention of eating disorders in adolescent girls. The grants will support development of evidenced-based interventions that target COVID-19-related stressors and potential barriers to early diagnosis. Learn more about the grants and the recipients from this HHS news release.
- HHS’s Office of Minority Health has awarded more than $3 million in grants to eight organizations for a new initiative to demonstrate policy effectiveness to promote Black youth mental health. This three-year initiative will seek to identify health and wellness policies that are successful in improving Black youth mental health, including suicide prevention. Learn more about the grants and the recipients from this HHS news release.
- HHS and its Administration for Community Living have released the “2022 National Strategy to Support Family Caregivers.” The strategy describes nearly 350 actions the federal government will take to support family caregivers in the coming year and more than 150 actions that can be adopted at other levels of government and across the private sector to build a system to support family caregivers. Learn more from this HHS news release and from the “2022 National Strategy to Support Family Caregivers.”
- HHS’s Agency for Healthcare Research and Quality (AHRQ) has announced a challenge competition to explore the resources and infrastructure needed to integrate real-world data from health care systems into systematic review findings. This work will help AHRQ understand if and how sources of data and information outside of traditional systematic reviews might be used alongside systematic reviews to improve health care decision-making, health care delivery, and patient outcomes. Learn more about the challenge, the prizes, and deadlines from this Federal Register notice.
- AHRQ seeks nominees from populations underrepresented in medicine to serve on its Initial Review Group, which conducts scientific peer review of AHRQ grant applications. Learn more from this Federal Register notice. Nominations are due by December 31.
- HHS’s Office of the Inspector General has reviewed the manner in which states oversee how the managed care plans serving their Medicaid population report their medical loss ratio and presented its findings and recommendations for how CMS can improve this oversight in the new report “CMS Has Opportunities To Strengthen States’ Oversight of Medicaid Managed Care Plans’ Reporting of Medical Loss Ratios.”
- HHS’s Office of the Inspector General has issued a report that is critical of the manner in which the FDA managed its emergency use authorization process during the COVID-19 crisis. During that process, the report concluded, the FDA chose enhancing the availability of tests over ensuring the quality of the tests it authorized, and as a result, it approved some tests of unsatisfactory quality. The report recommends steps the FDA should take to address this problem – recommendations with which the FDA agrees. Learn more from the HHS Office of the Inspector General report “FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing.”
Centers for Medicare & Medicaid Services
- On November 6, 2020, CMS published an interim final rule titled “Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency.” This interim final rule set forth certain requirements that states must follow to claim a temporary increase in federal matching funds for their Medicaid programs under the Families First Coronavirus Response Act. CMS is now considering modifying those requirements and is now soliciting additional information from the public. Specifically, CMS is considering returning to a previous interpretation under which, to be eligible for the temporary increase in federal Medicaid matching funds, a state would be required to keep its beneficiaries enrolled in Medicaid, if they were enrolled as of, on, or after March 18, 2020, and would not be permitted to reduce the amount, duration, or scope of their benefits or modify their cost-sharing after the effective date of the final rule. Learn more from this Federal Register notice. Comments are due by October 27.
- CMS has released a state plan amendment template and implementation guide for the Medicaid state plan option to cover health home services for Medicaid-eligible children with medically complex conditions, enacted as part of the Medicaid Services Investment and Accountability Act of 2019. For more information and links to additional resources, go here.
- CMS has written to state Medicaid directors to provide guidance to states as they consider transitioning from Resource Utilization Groups (RUGs) to the Patient-Driven Payment Model (PDPM) to pay Medicaid nursing facilities and also incorporating PDPM payments as the basis for nursing facility upper-payment limit demonstrations. This guidance is important for states because CMS will no longer support the Medicare RUGs system after October 1, 2023. Learn more from the CMS letter to state Medicaid directors.
- CMS has posted a new edition of MLN Connects, its online newsletter with information about Medicare reimbursement matters. The latest edition includes items about the revised enrollment for eligible ordering/physicians and other eligible professionals form (CMS 8550); the October update of the quarterly average sales price Medicare Part B drug pricing files; the October update of the hospital outpatient prospective payment system; and new resources on the hospice quality reporting program. Find this and more in the latest edition of MLN Connects.
- CMS has approved the extension of Medicaid and Children’s Health Insurance Program (CHIP) coverage for 12 months after pregnancy in North Carolina. As a result, 24 states and the District of Columbia have now extended eligibility of postpartum coverage to 12 months, as temporarily authorized by the American Rescue Plan. Learn more from this HHS news release.
- CMS has made publicly available additional data about the ownership of nursing homes. This data, which covers approximately 15,000 Medicare-certified nursing homes, seeks to give state licensing officials, state and federal law enforcement, researchers, and the public an enhanced ability to identify common owners of nursing homes across nursing home locations and can be linked to other data sources to identify the performance of facilities under common ownership, such as owners affiliated with multiple nursing homes with a record of poor performance. Learn more about this initiative and find where to obtain this data from this HHS news release.
- The CDC has issued recommendations to prevent occupationally acquired monkeypox infection among health care workers. Go here to find those recommendations and links to other resources.
- The CDC has posted a series of updates about monkeypox-related issues.
- The CDC has posted an updated map showing the distribution of 25,162 confirmed cases of monkeypox in the U.S. as of September 16.
Centers for Disease Control and Prevention
- The CDC has updated its interim infection prevention and control recommendations for health care workers during the COVID-19 pandemic. The update addresses the changing role of vaccine status in infection prevention and control, use of personal protective equipment, test frequency, health care worker screenings, and more. Find the updated recommendations here.
- CMS has updated its guidance and recommendations for a number of COVID-19 issues, including clinical care information; mitigating staff shortages; and managing health care workers who have been exposed to or diagnosed with COVID-19.
- The CDC has awarded $90 million in five-year grants to five state public health departments to establish a new Pathogen Genomics Centers of Excellence network. The network is intended to foster and improve innovation and technical capacity in pathogen genomics, molecular epidemiology, and bioinformatics to better prevent, control, and respond to microbial threats of public health importance. Learn more about the grants, the recipients, and the organizations that will be working with the state health departments from this CDC news release.
- Last week the CDC held a webinar on evaluating and supporting patients presenting with cardiovascular symptoms following COVID-19. To learn more, see a video of the webinar, the slides presented during the event, and a transcript of the webinar.
- The CDC has posted information about how it is surveying individuals who suffer from myocarditis as a side effect of a COVID-19 vaccine. Learn more here.
- The CDC has published its fall vaccination operational planning guide, which has information on its fall COVID-19 vaccine campaign, including upcoming pediatric bivalent COVID-19 vaccines as boosters for children ages five to 11.
Food and Drug Administration
- The FDA has issued new guidance to help facilitate the availability of naloxone to prevent opioid overdoses and reduce deaths.
- The FDA has issued guidance on the exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency. Find that guidance here.
- The FDA seeks nominees to serve on its Tobacco Products Scientific Advisory Committee. Nominations will be accepted for upcoming vacancies effective January 31, 2023. The deadline for submitting nominations for current vacancies is November 28. Learn more from this Federal Register notice.
Medicaid and CHIP Payment and Access Commission (MACPAC)
- MACPAC has written to the House Energy and Commerce Committee in response to that committee’s request for information on policies that affect individuals with disabilities. The request sought stakeholder input on a wide array of Medicaid and other long-term-care issues, with a focus on three areas: access to long-term services, accommodations in the community, and barriers to integrated employment. Find MACPAC’s letter here.
- MACPAC met recently in Washington, D.C. to address a number of Medicaid- and CHIP-related policy issues. Following this meeting agenda, the commissioners heard and discussed the following presentations:
- Background on Medicaid Race and Ethnicity Data Collection and Reporting
- State Strategies and Stakeholder Engagement for Unwinding the Public Health Emergency Continuous Coverage Requirement
- Improving Rate Setting and Risk Mitigation in Medicaid Managed Care
- Principles for Assessing Medicaid Nursing Facility Payments Relative to Costs
- Countercyclical Disproportionate Share Hospital Policies
- Medicaid Coverage of Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
- Review of Proposed Rule on Core Set Reporting and Congressional Request for Information on Long-term Services and Supports
- Panel on Integrating Care for Dually Eligible Beneficiaries in Medicaid Fee-for Service
CMS – Physicians, Nurses, and Allied Health Professionals Open-Door Forum – September 28
CMS will hold a virtual open-door forum for physicians, nurses, and allied health professionals on Wednesday, September 28 at 2:00 (eastern). Learn more about the forum and how to participate from this CMS announcement.
CDC – Dengue Virus Webinar – September 29
The CDC will hold a webinar on dengue virus in the U.S. on Thursday, September 29 at 2:00 (eastern). During this webinar presenters will discuss the current global and domestic dengue epidemiology and its relevance for clinicians in the U.S. and review dengue clinical classification, diagnosis, and general treatment guidelines. Continuing education credits are available. Learn more about the webinar and how to participate from this CDC notice.
MedPAC – September 29-30
The next meeting of members of the Medicare Payment Advisory Commission (MedPAC) will be held virtually on Thursday, September 29 and Friday, September 30. Find an agenda for the meeting here. Separate registration is required for three different segments of the meeting and links for registration can be found in the agenda.
FDA – Oncologic Drugs Advisory Committee – October 28
The FDA’s Oncologic Drugs Advisory Committee will meet virtually on Friday, October 28 at 10:00 (eastern). The general function of this committee is to provide advice and recommendations to the FDA on regulatory issues. Learn more about the meeting, including about the docket, how to submit comments, and how to participate, from this Federal Register notice.