The following is the latest health policy news from the federal government for April 28 – May 4.  Some of the language used below is taken directly from government documents.

End of the COVID-19 Public Health Emergency

  • DeBrunner & Associates has prepared a summary of the status of selected government health care waivers and flexibilities upon the expiration of the COVID-19 public health emergency on May 11. The DeBrunner summary covers telehealth, COVID-19 treatment and coverage, flexible hospital operations, long-term-care hospitals, inpatient rehabilitation facilities and units, patient cost-sharing, and state Medicaid waivers.  Find the summary here.
  • The COVID-19 public health emergency led to the temporary creation of a number of flexibilities in the delivery of health care, including one issued by the Drug Enforcement Agency (DEA) that made possible prescribing controlled medications via telehealth.  With the coming end of the public health emergency on May 11, and with it the expiration of some but not all COVID-related flexibilities, the DEA has announced that it is temporarily extending this flexibility while continuing to evaluate the situation.  It has submitted a draft regulation to the Office of Management and Budget to this effect but will provide no further information about it until it is published in the Federal Register at a later date.
  • The White House has announced that it will end the COVID-19 vaccine requirements for federal employees, federal contractors, and international air travelers at the end of the day on May 11, the same day that the COVID-19 public health emergency ends.  In addition, HHS and the Department of Homeland Security will start the process of ending their vaccination requirements for CMS-certified health care facilities, Head Start educators, and certain non-citizens at the land border.  Learn more from this White House announcement.
  • CMS has posted a consumer-oriented guide on insurance coverage of over-the-counter COVID-19 tests after the public health emergency ends on May 11.  Find that guide here.
  • During the COVID-19 public health emergency, HHS’s Office of the Inspector General issued policy statements and information about the degree to which it would enforce certain federal requirements during the public health emergency.  With that emergency ending on May 11, the office has now posted information describing those policy statements and explaining that the flexibilities they conferred will end after May 11.  Find that information here.
  • CMS has posted an FAQ that addresses its waivers and flexibilities upon the end of the COVID-19 public health emergency.  Find it here.
  • CMS has updated its “COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing” document to indicate that this FAQ will expire at the end of the COVID-19 public health emergency and will not be updated and directing stakeholders to other agency resources for answers to frequently asked questions.  Go here to learn more.

Proposed Medicaid Regulations

CMS has proposed two new Medicaid regulations:  “Ensuring Access to Medicaid Services” and “Managed Care Access, Finance, and Quality.”  Together, they seek to strengthen access to and quality of care across Medicaid and the Children’s Health Insurance Program (CHIP).  If adopted, the rules would establish new national standards for access to care for Medicaid and CHIP beneficiaries regardless of whether that care is provided through managed care or through fee-for-service programs.  Together, the proposed access and managed care rules include new and updated requirements that seek to establish access standards and a consistent way to transparently review and assess Medicaid payment rates across states.  The rules also propose standards to enable enrollees to compare plans based on quality and access to providers.  Highlights include:

  • Establishing national maximum standards for certain appointment wait times for Medicaid or CHIP managed care enrollees and stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid or CHIP managed care plans.
  • Requiring states to conduct independent secret shopper surveys of Medicaid or CHIP managed care plans to verify compliance with appointment wait time standards and to identify where provider directories are inaccurate.
  • Creating new payment transparency requirements for states by requiring disclosure of provider payment rates in both fee-for-service programs and managed care.
  • Introducing regulatory changes that would enhance states’ ability to use state directed managed care payments as part of value-based purchasing programs and reduce states’ need to obtain prior approval for some state directed payments and requiring states to ensure that each provider receiving a state directed payment attest that it does not participate in any arrangement that holds taxpayers harmless for the cost of a tax in violation of federal requirements.
  • Establishing additional transparency and interested party engagement requirements for setting Medicaid payment rates for home- and community-based services and a requirement that at least 80 percent of Medicaid payments for personal care, homemaker, and home health aide services must be spent on compensation for direct care workers.
  • Creating timeliness-of-access measures for home- and community-based services and strengthening safeguards to ensure beneficiary health and welfare and to promote health equity.
  • Strengthening how states use state medical care advisory committees.
  • Requiring states to conduct enrollee experience surveys in Medicaid managed care annually for each managed care plan to gather input directly from enrollees.
  • Establishing a framework for states to implement a Medicaid or CHIP quality rating system.

Learn more about the proposed regulations from the following resources:

The deadline for submitting stakeholder comments is July 3.

Centers for Medicare & Medicaid Services

  • CMS has issued its annual call for proposed new measures for hospitals and critical access hospitals participating in the Medicare Promoting Interoperability Program.  Learn more about the priorities CMS seeks to address this year and how to propose new measures from this CMS notice, which includes the form on which submissions must be presented.  The deadline for submissions is July 1.
  • CMS has announced that although current flexibilities in the Medicare Diabetes Prevention Program permitted pursuant to regulations issued during the COVID-19 public health emergency are scheduled to expire on May 11, it is extending to December 31 the period during which in-person delivery of program services can be suspended.  Learn more about the extension of this deadline and its application from this regulatory announcement, which includes a link to a Federal Register notice.
  • CMS has posted an article on its blog about the role of data in the agency’s oversight of organ procurement organizations.  Find that article here.
  • CMS has updated the ICD-10-PCS procedure code request application in the Medicare Electronic Application Request Information System (MEARIS).  Find the updates here.

Department of Health and Human Services

In the wake of HHS investigations of two hospitals that did not offer certain stabilizing care to individual experiencing emergency medical conditions involving pregnancy, potentially in violation of the Emergency Medical Treatment and Labor Act (EMTALA), HHS Secretary Xavier Becerra has issued a statement explaining that his department will “…use the full extent of our legal authority, consistent with orders from the courts, to enforce protections for individuals who seek emergency care – including when that care is an abortion.”  Go here to see an HHS announcement on this subject and Mr. Becerra’s statement.

HHS Newsletters

  • MLN Connects (CMS) – May 4
  • AHRQ News Now – May 2
  • HRSA eNews – May 4
  • HRSA – Office for the Advancement of Telehealth (announcements) – May 2

Provider Relief Fund

  • HHS has updated the Provider Relief Fund and ARP Rural Payments FAQ with eight modified answers to questions already included in that FAQ.  The revised answers can be found on pages 8, 11, 16, 26 (two questions), 34 (two questions), and 43 and address the return of unused payments; the use of payments after the end of the public health emergency; expenses eligible for reimbursement using Provider Relief Fund and America Rescue Plan payments; and reporting deadlines.  Providers that received these payment should go here to review the new information.
  • HHS has posted the following deadlines for certain Provider Relief Fund-related activities.
    • May 15 – the reporting portal opens for request to report late-approved providers.
    • June 2 – the reporting portal closes for request to report late-approved providers.
    • June 3 – deadline to apply Provider Relief Fund and/or American Rescue Plan rural funds to lost revenues.

Centers for Disease Control and Prevention

  • The CDC is inviting nominations for membership on its Healthcare Infection Control Practices Advisory Committee, which consists of 14 experts in fields including but not limited to infectious diseases, infection prevention, health care epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields.  Learn more about the committee and its work from this CDC announcement, which includes a link to a Federal Register notice.  The deadline for nominations is September 29.
  • The CDC has published the new statistical report “Changes in Prenatal Care Utilization:  United States, 2019–2021.”  Find it here.

Food and Drug Administration

  • The FDA has authorized a fourth Pfizer COVID-19 vaccine for certain immunocompromised children between the ages of six months and four years.  Learn more from this FDA updated emergency authorization letter and this updated fact sheet for health care professionals.
  • The FDA issued a statement to health care providers to inform them and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments.  These instruments may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only.  At this time, the FDA and Illumina have not received any reports indicating this vulnerability has been exploited.  Find that statement here.
  • The FDA has approved the first respiratory syncytial virus (RSV) vaccine for use in the United States.  The FDA has approved the vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.  Learn more from this FDA announcement.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • With Medicaid financing a significant portion of births, MACPAC has published an issue brief presenting evidence that midwives and the midwifery-led model of care provided in birth centers can improve maternal and child health outcomes at a lower overall cost to Medicaid and describing barriers to expanding that approach to care.  Find the MACPAC issue brief here.
  • The Government Accountability Office has named six new members to MACPAC:  Timothy Hill, vice president for client engagement at the American Institutes for Research; Carolyn Ingram, executive vice president of Molina Healthcare; Patti Killingsworth, senior vice president of long-term services and supports strategy at CareBridge; John McCarthy, founding partner at Speire Healthcare Strategies; Adrienne McFadden, M.D., chief medical officer of Medicaid at Elevance Health; and Jami Snyder, president and CEO of JSN Strategies.  Learn more about the new MACPAC commissioners from this GAO news release.

Stakeholder Events

FDA – Considerations for Buprenorphine Initiation and Maintenance Care Public Meeting – May 10-11

In partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, the FDA has announced a virtual public meeting on Wednesday and Thursday, May 10-11, on considerations for buprenorphine initiation and maintenance care.  The meeting is for stakeholders, including people who use drugs, their families and community, harm reduction programs, health professionals from inpatient and outpatient settings, academic researchers, and federal partners and will explore real-world experiences and scientific evidence for buprenorphine initiation strategies as well as medication dosing and management during continued treatment across different care settings.  Go here for additional information about the two-day public meeting and how to register to participate.

CDC – Updated Recommendations for COVID-19 Vaccine Use Webinar – May 11

Through its Clinical Outreach and Communication Activity Program, the CDC will hold a webinar during which it will discuss updated COVID-19 vaccine recommendations by age group and for those who are immunocompromised.  The webinar also will highlight optional COVID-19 vaccine doses for specific populations.  Learn more about the webinar, how to join it, and the continuing education credits that can be obtained by participating from this CDC notice.

CDC – Healthcare Infection Control Practices Advisory Committee Meeting – June 8-9

The CDC’s Healthcare Infection Control Practices Advisory Committee will hold public meetings on Thursday, June 8 and Friday, June 9 at 9:00 (eastern) on both days.  The agenda includes updates on CDC activities for the prevention of health care-associated infections and reports from various subcommittees.  Individuals may participate in person or virtually and registration is required.  Learn more about the meeting and how to register and participate from this CDC announcement.