The following is the latest health policy news from the federal government as of 2:30 p.m. on Wednesday, July 20.  Some of the language used below is taken directly from government documents.

White House

The White House COVID-19 response team has briefed the press about the administration’s latest efforts in the response to COVID-19.  Find a transcript of that teleconference briefing here.

COVID-19 Public Health Emergency

HHS Secretary Xavier Becerra has renewed the COVID-19 public health emergency effective July 15.

Centers for Medicare & Medicaid Services

  • CMS has released its proposed Medicare outpatient prospective payment system regulation for calendar year 2023.  Highlights include:
    • A proposed rate increase of 2.7 percent for Medicare-covered outpatient services.
    • A proposed rate increase of 2.7 percent for ambulatory surgical center services.
    • A proposal to pay rural sole-community hospitals the full outpatient prospective payment system rate, rather than the site-neutral, physician fee schedule equivalent rate, for clinic visits in excepted off-campus provider-based departments.
    • An incomplete proposal for 340B payments in which CMS is formally proposing a payment rate of average sale price minus 22.5 percent for drugs and biologicals acquired through the 340B program, as it has been in recent years, but the proposed rule adds that CMS “…fully anticipate(s) applying a rate of ASP plus six percent to such drugs and biologicals in the final rule for CY 2023, in light of the Supreme Court’s recent decision.  We are still evaluating how to apply the Supreme Court’s recent decision to prior calendar years.”
    • Proposals on various aspects of the new Rural Emergency Hospital program that will begin next year, including payment policies, provider enrollment, and updates of the physician self-referral law for the Rural Emergency Hospitals.
    • A proposal to remove 10 services from Medicare’s inpatient-only list and add eight new services to that list.

To learn more about the proposed 2023 Medicare outpatient prospective payment system regulation, see the following resources:

Stakeholder comments are due by September 13.

  • CMS has posted new editions of MLN Connects, its online newsletter with information about Medicare reimbursement matters.  The new issues include items about FDA authorization for pharmacists to prescribe Paxlovid for COVID-19 patients under limited circumstances; new codes for administering the Moderna vaccine to children as young as six months; changes in the nursing home five-star rating system; claims processing instructions for the new hepatitis B vaccine; new billing codes for the recently approved Novavax COVID-19 vaccine; and more.  Find it all here and here.
  • CMS has informed potential Enhancing Oncology Model applicants and participants that the Merit-based Incentive Payment System (MIPS) payment adjustment factors will not apply to monthly Enhancing Oncology Services payments in the Enhanced Oncology Model.  Learn more from this CMS explanation and the formal Federal Register notice.  This takes effect on August 15.
  • CMS has informed states and stakeholders that as a result of the 2022 Additional Ukraine Supplemental Appropriations Act and the Uniting for Ukraine program, many displaced Ukrainian nationals arriving in the U.S. are eligible for health insurance through Medicaid, CHIP, the health insurance marketplace, or the Refugee Medical Assistance program.  Learn more from this CMS fact sheet.
  • CMS is in the process of notifying post-acute-care facilities that have been found to be out of compliance with their Quality Reporting Program requirements for 2021; this will affect their 2023 annual payment update.  Facilities out of compliance may submit a request for reconsideration to CMS via email no later than 11:59 pm on August 11.  For instructions on how inpatient rehabilitation facilities should go about this, go here; for skilled nursing facilities, go here; for long-term hospitals, go here; and for hospice providers, go here.
  • Citing its need for the past two years to focus on the federal response to COVID-19, CMS has extended for one year its deadline under the 2019 proposed rule “Medicare and Medicaid Programs; Requirements for Long-Term Care (LTC) Facilities:  Provisions to Promote Efficiency and Transparency” to publish Medicare and Medicaid long-term-care facility requirements that the agency identifies as unnecessary, obsolete, or excessively burdensome.  Learn more from this Federal Register notice.
  • CMS is recruiting hospice, home health, and health equity stakeholders to serve on a technical expert panel to provide input on a proposed health equity structural composite measure for both hospice and home health care settings for its hospice and home health quality reporting programs.  Learn more about the work the panel will undertake, the capabilities the agency seeks, the work commitment involved, and how to submit nominations in this agency notice.  Nominations are due by August 12.

Department of Health and Human Services

  • HHS and CMS have awarded $49 million to organizations on the front lines of reducing uninsured rates and connecting more children, parents, and families to health care coverage.  Grant recipients will provide enrollment and renewal assistance to children and their families and expectant parents to promote improved maternal and infant health outcomes.  CMS issued 36 cooperative agreements in 20 states through Medicaid’s Connecting Kids to Coverage program.  Grant recipients, including state and local governments, tribal organizations, federal health safety net organizations, non-profits, and schools, will each receive up to $1.5 million over three years to advance Medicaid and CHIP enrollment and retention.  Learn more about the grants and their purpose from this HHS news release and find a list of grant recipients here.
  • HHS has issued guidance to retail pharmacies clarifying their obligations to ensure comprehensive reproductive health care services.   The guidance makes clear that as recipients of federal financial assistance, including Medicare and Medicaid payments, pharmacies are prohibited under law from discriminating based on race, color, national origin, sex, age, and disability in their programs and activities and that this includes supplying prescribed medications; making determinations regarding the suitability of prescribed medications for a patient; and advising patients about prescribed medications and how to take them.  Learn more from this HHS news release.
  • HHS’s Health Resources and Services Administration (HRSA) reminds providers that they can encourage greater use of telehealth among their lower-income patients by helping some of those patients obtain low-cost or even in some cases no-cost internet services and internet-connected devices.  Among those who may be eligible for several such federal programs are SNAP recipients, Medicaid beneficiaries, recipients of SSI and federal public housing assistance, those who receive veterans pensions or survivor benefits, and others.  Learn more from this HRSA notice.
  • The U.S. has shifted from the 10-digit national suicide prevention hotline to a new number – 988 – for 24 hours-a-day, seven-days-a-week assistance.  Learn more from this HHS news release.

Centers for Disease Control and Prevention

  • The CDC has endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that Novavax’s COVID-19 vaccine be used as another primary series option for adults ages 18 years and older.  Novavax’s COVID-19 vaccine, which will be available in the coming weeks, is a more familiar type of COVID-19 vaccine technology for adults:  unlike mRNA vaccines, which are based on a new technology, the technology underlying the Novavax vaccine has been in use for more than 30 years.  Learn more from this CDC news release.
  • A third and fourth COVID-19 vaccine dose offered substantial protection to adults with healthy immune systems who were eligible to receive them during omicron variant evolution in early 2022, according to a new CDC study.  The findings of this study, in conjunction with recently published data showing that people infected with BA.2 also may have antibodies that can protect against illness from BA.5, suggest that currently available vaccines may provide protection against serious illness caused by the currently circulating BA.5 variant.  Learn more from this CDC announcement and from the study itself.
  • The CDC has updated its information about the potential impact of COVID-19 vaccines on both men and women planning for pregnancy.
  • The CDC also has updated its information about reported adverse effects of COVID-19 vaccines.
  • The CDC has updated its information for people who are concerned that they might have an allergic reaction to a COVID-19 vaccine or who believe they are having such a reaction after vaccination.  Find the updated information here.

Food and Drug Administration

  • The FDA has issued emergency use authorization for the Novavax COVID-19 vaccine to be administered to individuals 18 years of age and older.  Learn more, including the underlying rationale for the FDA’s decision, from this agency announcement.
  • The FDA has updated its information about genotyping tests authorized for the identification and differentiation of specific COVID-19 mutations, lineages, and variants.  Find the updated information here.

National Institutes of Health

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the omicron variant, antibody levels decrease substantially within three months, according to a new clinical trial sponsored by the NIH.  Learn more about the trial and the findings’ implications from this NIH news release.

Monkeypox

  • HHS has ordered another 2.5 million doses of monkeypox vaccine.  This order follows a July 1 order for 2.5 million doses that will begin arriving in the Strategic National Stockpile over the next year.  Deliveries from today’s 2.5 million dose order will begin arriving at the Strategic National Stockpile in 2023, bringing the federal government’s available supply of vaccine to nearly seven million doses by mid-2023.  Learn more about the newly ordered vaccine, the distribution of recently released supplies, and improvements in the national capacity to analyze monkeypox test results from this HHS news release.
  • The FDA has issued a notice advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus.  The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing.  Testing samples not taken from a lesion may lead to false test results.  Learn more from this FDA notice.
  • The CDC has posted an updated map showing the distribution of 2108 confirmed cases of monkeypox in the U.S. as of July 19.

Medicare Payment Advisory Commission (MedPAC)

MedPAC has released its 2022 data book on health care spending and the Medicare program.  The publication provides data on Medicare spending, demographics of the Medicare population, beneficiaries’ access to care, quality of care in the program, and more.  Learn more from the MedPAC data book “Health Care Spending and the Medicare Program.”

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • A new MACPAC issue brief analyzes the effects of churn on health service use among adult Medicaid beneficiaries using 2017-2019 national data.  The report examines the rates in emergency department visits and hospitalizations related to four ambulatory care-sensitive conditions before and after experiencing a gap in coverage.  Read about what this analysis reveals in the new MACPAC issue brief “Effects of Churn on Potentially Preventable Hospital Use.”
  • Another new MACPAC issue brief summarizes the commission’s analysis of insurance affordability program enrollment data and beneficiary transitions among those programs in 2018 and reviews policy approaches that have been proposed to help reduce gaps in coverage.  Learn more from the MACPAC issue brief “Transitions Between Medicaid, CHIP, and Exchange Coverage.”

Stakeholder Events

CMS – CMS Rural Health Open Door Forum – July 21

CMS will hold a rural health open door forum on Thursday, July 21 at 2:00 p.m. (eastern).  Subjects on the agenda include Rural Emergency Hospital conditions of participation, payment policies, and Stark exceptions; updates of the hospital outpatient prospective payment system and ambulatory surgical center payment rates; and proposed updates of the physician fee schedule.  This forum will be by conference call only; to participate, dial 888-455-1397 and use reference code password 5109694.

CMS/Center for Medicare and Medicaid Innovation – Alternative Payment Model Listening Session – July 21

CMS’s Center for Medicare and Medicaid Innovation will hold a listening session on the transition of the Alternative Payment Model incentives in performance year 2023 (payment year 2025).  The agency bills this event as “… an opportunity for CMS to hear from providers and participants in APMs on their perspectives on the forthcoming end of the lump sum APM Incentive Payment.”  The listening session will be held on Thursday, July 21 at 2:00 (eastern).  Go here to register to participate and to submit questions to be addressed during the meeting.

National Advisory Council for Healthcare Research and Quality – July 21

The National Advisory Council for Healthcare Research and Quality, which advises the Secretary of the Department of Health and Human Services and the Director of Agency for Healthcare Research and Quality (AHRQ) on matters involving to AHRQ’s mission, will meet on Thursday, July 21 at 12:30 p.m. (eastern).  Council members will meet in person but the public is invited only virtually.  Learn more about the council, the agenda for the meeting, and how to participate in the meeting from this Federal Register notice.

CDC – Novavax COVID-19 vaccine recommendations – July 28

The CDC will hold a webinar on Thursday, July 28 at 2:00 (eastern) to present the CDC’s new guidance on the Novavax COVID-19 vaccine for adults ages 18 years and older, including adults who are moderately or severely immunocompromised.  Learn more about the webinar’s objectives, the presenters, how to qualify for continuing education credits, and how to join the event from this CDC notice.

CMS – Digital Quality Measurement – August 10 and 11

CMS will hold a webinar titled “Strategic Roadmap for Advancing Digital Quality Measurement” to highlight its multi-pronged strategy to provide better access to usable, timely data to improve quality measurement and patient care.  The webinar will be offered twice:  on Wednesday, August 10 at 3:00 (eastern) and Thursday, August 11 at noon (eastern).  To register for the August 10 session, go here; to register for the August 11 session, go here.  Space is limited so CMS encourages early registration.

HHS Office of the Assistant Secretary for Preparedness and Response – Disaster Available Supplies in Hospitals Tool – August 15

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on Monday, August 15 at 11:30 (eastern) to talk to hospitals about its Disaster Available Supplies in Hospitals Tool (DASH), an online, interactive tool for hospital emergency planners and supply chain staff to estimate supplies that may be needed immediately during various emergencies based on their hospital’s characteristics.  Speakers will provide an overview and demonstration of DASH and share information on how it may be used from both the hospital and supply chain perspective.  Go here to learn more about the webinar and the speakers and how to register to participate; registration is limited to 1000 participants, although the event will be recorded and made available at a later date.