The following is the latest health policy news from the federal government for the week of October 7 to October 13. Some of the language used below is taken directly from government documents.
Public Health Emergency Declaration
- HHS Secretary Becerra has renewed the COVID-19 Public Health Emergency declaration. This renewal does not provide the promised 60-day notice of the PHE’s end, so for now, the current declaration is set expire on January 11, 2023. We will continue to update you on any changes to the PHE timeline. You can view the PHE renewal here.
- The White House COVID-19 response team has briefed the press on the most recent aspects of the federal response to the pandemic. Find a transcript of that briefing here.
Centers for Medicare & Medicaid Services
- CMS has released its 2023 star ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans. Plans are rated on a one-to-five scale, with one star representing poor performance and five stars representing excellent performance. Star ratings are released annually and reflect the experiences of people enrolled in Medicare Advantage and Part D prescription drug plans. Learn more from this CMS news release and an accompanying fact sheet.
- In September, CMS rescinded a policy adopted in response to the COVID-19 emergency that it would not cite facilities with a CLIA Certificate of Waiver when they perform authorized COVID-19 molecular or antigen POC tests on asymptomatic individuals outside of the test’s authorization. In addition, CMS had not been citing non-waived facilities when modified authorized, cleared, or approved COVID-19 molecular or antigen POC tests were performed in such manner without establishing performance specifications. CMS has now rescinded its September announcement and will again suspend citing laboratories for the activities described in its original policy. See CMS’s letter reversing its September announcement.
- The latest edition of MLN Connects, CMS’s online newsletter with information about Medicare payment issues, includes information about the agency’s response to a recent federal court ruling rejecting its current method of paying for 340B-covered drugs, updated billing information for skilled nursing and home health services, and more. Find it here.
Department of Health and Human Services
- A new HHS report shows that the country’s vaccination program is linked to more than 650,000 fewer COVID-19 hospitalizations and more than 300,000 fewer deaths among seniors and other Americans enrolled in Medicare. Learn more from this HHS news release and the report “Reductions in Deaths and Hospitalizations Associated with COVID-19 Vaccinations Among Medicare Beneficiaries: Full Year 2021 Estimates.”
- HHS’s Health Resources and Services Administration (HRSA) is accepting applications for funding under the Rural Health Network Development Planning Program to promote the planning and development of integrated health care networks to address the following legislative aims: achieve efficiencies; expand access to, coordinate, and improve the quality of basic health care services and associated health outcomes; and strengthen the rural health care system as a whole. This program seeks to support one year of planning and bring together key parts of a rural health care delivery system, particularly those entities that may not have collaborated in the past, to establish and/or improve local capacity to strengthen rural community health interventions and enhance care coordination. HRSA anticipates awarding 20 grants of up to $100,000. Learn more from this funding opportunity notice. Applications are due by January 6.
- In the wake of a cyber-security breach of a major U.S. health system, HHS has issued the warning report “Abuse of Legitimate Security Tools and Health Sector Cybersecurity” that outlines how established security tools can be used against the systems they are designed to protect.
Department of the Treasury
- The Treasury Department’s Internal Revenue Service has issued a regulation amending previous regulations regarding eligibility for the premium tax credit to provide that affordability of employer-sponsored minimum essential coverage for family members of an employee is determined based on the employee’s share of the cost of covering the employee and the employee’s family members and not the cost of covering only the employee. The final regulations also add a minimum value rule for family members of employees based on the benefits provided to the family members. This final regulation affects taxpayers who enroll, or enroll a family member, in individual health insurance coverage through a Health Insurance Exchange and who may be allowed a premium tax credit for the coverage. This regulation addresses what has been referred to as the Affordable Care Act’s “family glitch” that made health insurance more costly for families. Find the regulation in this Federal Register notice. It takes effect on December 12.
Food and Drug Administration
- The FDA has authorized use of the Moderna COVID-19 vaccine bivalent and the Pfizer COVID-19 vaccine bivalent as a single booster dose in younger age groups. It authorized use of the Moderna COVID-19 vaccine bivalent for administration at least two months following completion of primary or booster vaccination in children down to six years of age and authorized use of the Pfizer COVID-19 vaccine bivalent for administration at least two months following completion of primary or booster vaccination in children down to five years of age. Learn more from this FDA news release.
- The FDA has approved a vaccine for use during the third trimester of pregnancy to prevent whooping cough in infants younger than two months of age. Learn more from this FDA news release.
- The FDA has issued emergency use authorization for the first commercial test to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The new test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to certified laboratories. Learn more from this FDA announcement and the emergency use authorization letter for the new test.
Centers for Disease Control and Prevention
- The CDC has updated its clinical information for the management of ocular monkeypox infection.
- The CDC has published research comparing the incidence of monkeypox among vaccinated and unvaccinated persons. The study found that across 32 jurisdictions in the U.S., among males aged 18-49 years eligible for vaccination, the incidence of monkeypox was 14 times greater for unvaccinated males than for those who had received a first dose vaccine at least two weeks earlier. Find the CDC report here.
- The CDC has issued a health advisory about a recently confirmed outbreak of Ebola in Uganda to summarize its recommendations for U.S. public health departments and clinicians, case identification and testing, and clinical laboratory biosafety considerations. The alert notes that no suspected, probable, or confirmed Ebola cases related to this outbreak have yet been reported in U.S. but that as a precaution and to remind clinicians about best practices, the agency is communicating with public health departments, public health laboratories, and health care workers in the U.S. to raise awareness of this outbreak. Find the CDC Ebola health advisory here.
Medicare Payment Advisory Commission (MedPAC)
- At MedPAC’s last public meeting commissioners and staff discussed safety-net clinicians, the prototype for a new Medicare post-acute care payment system, nursing facility staffing, expansion of telehealth, Medicare inpatient psychiatric facility care, Medicare Part D drug rebates and discounts, and more. Find a transcript of that meeting here.
HHS – Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project – October 18-20
HHS’s Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project will offer three days of virtual seminars from Tuesday, October 18 through Thursday, October 20 at 2:00 (eastern) each day. Scheduled webinars are “HCUP Database Overview,” “Overview of HCUP Products and Tools,” and “Overview of HCUP Products and Tools.” Go here to learn more about the seminars and how to participate.
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.
HHS – Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project – November 2-3
HHS’s Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project will offer a virtual two-day workshop on “Planning Your HCUP Analysis” on Wednesday, November 2 and Thursday, November 3 at noon (eastern). Go here to find the agenda and information about how to participate.
CDC – Healthcare Infection Control Practices Advisory Committee– November 3
The CDC’s Healthcare Infection Control Practices Advisory Committee will hold a virtual public meeting on Thursday, November 3 at noon (eastern). The committee is charged with providing advice and guidance to various CDC offices on the practice of health care infection prevention and control; (2) strategies for surveillance, prevention, and control of infections, antimicrobial resistance, and related events in settings where care is provided; and (3) periodic updating of CDC guidelines and other policy statements regarding prevention of health care-associated infections and health care-related conditions. Learn more about the committee, see the agenda, and find information about how to participate from this Federal Register notice.
FDA – Cardiovascular and Renal Drugs Advisory Committee – December 14
The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on Wednesday, December 14 at 9:00 (eastern). For information on the meeting’s agenda, the docket the committee has created for the meeting, how to submit comments and papers, and how to join the meeting, see this Federal Register notice.
HHS – New Technology Town Hall – December 14-15
HHS will hold a new technology town hall meeting on Wednesday, December 14 and Thursday, December 15, with both virtual sessions to begin at 9:00 (eastern), to discuss FY 2024 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties may present comments, recommendations, and data regarding whether the FY 2024 new medical services and technologies applications meet the substantial clinical improvement criterion. Learn more about the meeting and its purpose and how to participate from this Federal Register notice.