The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, November 4. Some of the language used below is taken directly from government documents.
New Federal Vaccination Requirements
CMS has unveiled its new COVID-19 vaccine requirements for health care providers that receive reimbursement from the federal government. The highlights include:
- CMS is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs.
- The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types: ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, hospitals, intermediate-care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies, public health agencies as providers of outpatient physical therapy and speech-language pathology services, psychiatric residential treatment facilities, Programs for All-Inclusive Care for the Elderly Organizations (PACE), rural health clinics/federally qualified health centers, and long-term care facilities.
- Facilities covered by this regulation must establish a policy ensuring that all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices.
- The regulation addresses who, among health care facilities’ employees, are subject to this requirement. These requirements, it notes, must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients: facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.
- These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff.
- Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. CMS has concluded that it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those who physically enter facilities, clinics, homes, or other sites of care.
- Transplant centers, psychiatric hospitals, and swing beds are governed by the infection control conditions of participation for hospitals and are thus subject to the staff vaccination requirements issued in this rule.
- Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this rule. Providers should identify and monitor these individuals as a part of implementing the policies and procedures of this rule.
- The rule encompasses administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services staff, and others. Regulators considered excluding individual staff members who are present at the site of care less frequently than once a week from these vaccination requirements but were concerned that this might lead to confusion or fragmented care, so any individual who performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated.
- Regulators noted that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals. Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), delivery, or repair personnel.
- When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this rule, facilities are told to consider frequency of presence, services provided, and proximity to patients and staff. For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements because they are using the same common areas used by staff, patients, and visitors.
- To learn more, please consult the following resources:
- a CMS news release
- an FAQ
- the interim final rule
- a White House fact sheet on this new policy and another workplace vaccination rule issued by the Occupational Safety and Health Administration (OSHA)
- The transcript of a background press call on the CMS and OSHA rules for vaccinations in the workplace
- OSHA has announced a new emergency temporary standard to protect more than 84 million workers from the spread of COVID-19 on the job. Under this standard, covered employers (those with 100 or more employees) must develop, implement, and enforce a mandatory COVID-19 vaccination policy unless they adopt a policy requiring employees to choose either to be vaccinated or to undergo regular COVID-19 testing and wear a face covering at work. Learn more from this OSHA news release and the agency’s formal Emergency Testing Standard, as published in the Federal Register.
New Medicare Regulations
CMS has released a number of final Medicare regulations. The following are those final rules and links to additional information about them.
- Hospital outpatient prospective payment system, ambulatory surgical center prospective payment system, price transparency, and radiation oncology model rule – changes include a two percent rate increase; restoration of the inpatient-only procedure list and most procedures that were removed from that list last year; continuation of 340B payments at average sale price minus 22.5 percent; changes in the hospital price transparency rule that leave hospitals with more than 30 beds subject to fines of up to $5500 a day or more than $2 million a year; changes in the quality reporting program, including a measure for COVID-19 vaccination rate among health care workers; and some changes in the Radiation Oncology Model program that begins on January 1, 2022, including invoking its “Extreme and Uncontrollable Circumstances Policy” for the program. To learn more, see the following resources:
- For more on the “Extreme and Uncontrollable Circumstances Policy” and its application to the Radiation Oncology Model, go here and scroll down.
- Physician fee schedule – changes include an overall reduction of nearly nine percent in physician payments; a reduction of the conversion factor from the current $34.89 to $33.59; and provisions for the expanded use of telehealth. To learn more, see the following resources:
- Home health prospective payment system – changes include a 3.2 percent rate increase, changes in the Medicare conditions of participation, and provisions for expanded use of telehealth. To learn more, see the following resources:
- CMS has issued a final rule that updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2022. This rule also finalizes updates to the Acute Kidney Injury program dialysis payment rate for renal dialysis services furnished by ESRD facilities. It also finalizes modifications to the ESRD Treatment Choices Model policies to encourage certain health care providers to reduce disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status. To learn more, see the following resources:
The White House
- The White House has posted a transcript of the November 1 press briefing given by its COVID-19 response team and public officials and another for its November 3 briefing.
- Yesterday, House Democrats released the text of its reconciliation bill, H.R. 5376 – the Build Back Better Act. This bill includes a provision that provides a glide-path to ending the enhanced 6.2% Medicaid federal matching percentage established by the Families First Coronavirus Response Act passed in March last year. The enhanced FMAP would be phased out as follows:
- April 1, 2022, the enhanced FMAP lowered to 3.0 percentage points;
- July 1, 2022, enhanced FMAP lowered to 1.5 percentage points;
- October 1, 2022, enhanced FMAP expires.
- House Speaker Nancy Pelosi hopes the House will vote on the domestic spending reconciliation bill as early as this evening, to be followed by a vote on the bipartisan, Senate-passed infrastructure bill on Friday. House Democrats have continued to negotiate changes in the reconciliation bill to gain more support, though it is unclear whether those changes have persuaded enough Democrats in the House to support the bill at this time. Also unclear is whether the House bill will comply with the Senate’s procedural rules or whether this bill will have the support of all 50 Democratic senators.
Provider Relief Fund: Phase 3 Payment Reconsideration
- The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated. Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology. Go here for further information. The deadline for submitting requests for reconsideration of Phase 3 payments is November 12.
Department of Health and Human Services
Health Policy News
- HHS has proposed eliminating the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) regulation, adopted in January of this year, that would have eliminated department regulations after ten years unless HHS took specific action to renew them. In proposing to reverse the rule, HHS cited its previous failure to consider stakeholder objections to the rule, the burden it would place on the agency, and its potentially negative effect on medically vulnerable populations. See HHS’s proposed rule overturning the SUNSET regulation in this Federal Register notice.
- HHS has awarded $3.37 billion in relief funds through the Low Income Home Energy Assistance Program (LIHEAP) to help low-income individuals and families afford home heating costs this winter and cover unpaid utility bills. This supplements $4.5 billion in LIHEAP funds from the American Rescue Plan Act that were released in May. Learn more about this new LIHEAP funding and how interested parties can apply for assistance in this HHS news release.
- HRSA has issued an interim update to its strategic plan to ensure alignment with the administration’s and HHS’s priorities, such as their emphasis on health equity, and the expansion of HRSA’s program responsibilities. Go here to learn about the updated interim plan.
- HRSA has opened its application process for three of its loan repayment programs with the support of an additional $800 million made available through the American Rescue Plan. Eligible clinicians providing primary medical, dental, behavioral health care services, or evidence-based substance use disorder treatment can qualify for loan repayment of up to:
- $50,000 for the NHSC Loan Repayment Program
- $75,000 for the NHSC Substance Use Disorder Workforce Loan Repayment Program
- 100,000 for the NHSC Rural Community Loan Repayment Program
Go here to learn more about eligible clinicians. Applications are due December 16.
- HHS’s Indian Health Service has announced $46.4 million in funding opportunities to address suicide, domestic violence, and substance abuse and for support for an integrative approach to the delivery of behavioral health services for American Indians and Alaska Natives. Go here to learn more about the funding opportunities. Applications are due February 2.
Centers for Medicare & Medicaid Services
- CMS has reminded eligible consumers and providers that coverage for COVID-19 vaccines for children from the ages of five to 11 is available without cost-sharing under Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and in the commercial market. Under the terms of the CDC’s COVID-19 Vaccination Program Provider Agreement, health care providers and other entities administering COVID-19 vaccines must agree not to deny anyone a COVID-19 vaccination based on their health coverage status and also must agree to administer COVID-19 vaccines at no out-of-pocket cost to recipients. Learn more from this CMS news release.
- CMS has posted a quick start guide to CLIA certification for COVID-19 testing in the workplace and an accompanying FAQ.
Health Policy News
- CMS has extended two deadlines affecting hospitals that participate in its Hospital Inpatient Quality Reporting Program and/or the Medicare Promoting Interoperability Program. As described in this CMS notice,
- The deadline for the submission of electronic clinical quality measure (eCQM) data for the calendar year 2021 reporting period, pertaining to the FY 2023 payment determination, has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
- The Medicare Promoting Interoperability Program attestation deadline for eligible hospitals and critical access hospitals has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
- CMS has posted the latest edition of MLN Connects, its online newsletter. Included in the new release are articles about changes for Medicare Advantage plan claims for COVID-19 vaccines and monoclonal antibodies that will take effect on January 1, 2022; changes in Medicare billing practices; a new web-based training program on post-acute care quality reporting programs; and more. Go here to see the latest edition of MLN Connects.
- CMS has released an updated fact sheet, based on recent legislative changes, to help states and advocacy organizations understand what health coverage options are available to Afghan evacuees. Find that fact sheet here.
Food and Drug Administration
- The FDA has authorized the Pfizer vaccine for emergency use in children five through 11 years of age. Learn more from the FDA’s news release announcing this authorization.
Centers for Disease Control and Prevention
- The CDC has endorsed its Advisory Committee on Immunization Practices’ recommendation that children five to 11 years of age be vaccinated against COVID-19 with the Pfizer pediatric vaccine. This expands vaccine recommendations to about 28 million children in the United States in this age group. Learn more from this CDC news release.
- A new CDC study has concluded that vaccination provides better protection against COVID-19 than a previous COVID-19 infection. Learn more from this CDC news release and a report on the research.
- The CDC has published research on the effectiveness of the two-dose COVID-19 vaccines in preventing COVID-19-related hospitalizations among immunocompromised adults.
- The CDC has updated its information about the Johnson & Johnson COVID-19 vaccine.
- The CDC has updated its FAQ about COVID-19 vaccines to reflect the recommendation that children between the ages of five and 11 years receive the Pfizer pediatric COVID-19 vaccine. Find the updated FAQ here.
- The CDC has updated its information on COVID-19 vaccines for children and teenagers.
- The CDC has updated its information about COVID-19 variants.
- The CDC has updated its discussion about clinical considerations associated with administering COVID-19 vaccines with information about the assessment of the risk of anaphylactic reaction to the vaccine and the management of such anaphylaxis should it occur. Find the information here.
- The CDC has updated its guidance for handling COVID-19 and COVID-19-suspected laboratory specimens.
National Institutes of Health
- The NIH’s Rapid Acceleration of Diagnostics initiative has announced the launch of the “When To Test Calculator for Individuals,” a companion to the version for organizations introduced last winter. By responding to just a few prompts, the new online individual impact calculator indicates whether a person should get a test and when. The calculator includes answers to frequently asked questions and links to resources on testing strategies and on obtaining supplies, including home tests. Learn more from this NIH announcement.
- The NIH will support a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with the virus during pregnancy. The study also will follow their offspring for any potential long-term effects. Learn more from this NIH news release.
Medicare Payment Advisory Commission (MedPAC)
- MedPAC has updated “Payment Basics,” its series of brief overviews of how Medicare’s payment systems function. The agency produces Payment Basics as a resource for policy-makers and others to better understand how Medicare pays for health care services. Much of the update reflects COVID-19-related payment changes. Find the series here.
Medicaid and CHIP Payment and Access Commission (MACPAC)
- MACPAC met on Thursday, October 28 and Friday, October 29. For a summary of the meeting and links to the agenda and presentations made during the meeting, go here.
- MACPAC has published a new issue brief that describes the use and oversight of upper-payment limit (UPL) payments for hospitals, nursing facilities, and physicians based on its review of provider-level data submitted by states to CMS to demonstrate compliance with UPL requirements. The brief concludes with a discussion of current policy issues, including the new requirement for CMS to make provider-level UPL data publicly available. Find the brief here.
Government Accountability Office (GAO)
- The GAO recently evaluated the effectiveness of the federal government’s organization of the distribution of COVID-19 vaccines and its communication about those efforts and has published its findings and recommendations in the new report “COVID-19: HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives.” Find a summary of the report here and the full report here.
Congressional Research Service
- The Congressional Research Service has updated its report “COVID-19 Variants: Vaccines, Diagnostics, and Therapeutics.”
Medicare Payment Advisory Commission (MedPAC) – November 8 and 9
MedPAC will hold virtual meetings on November 8 and 9. For information about times, agenda, and how to join the meeting go here.
CMS – Medicare Clinical Laboratory Fee Data Collection and Reporting Webinar – November 10
CMS will hold a webinar on Medicare clinical laboratory private payer data collection and reporting on Wednesday, November 10 at 3:30 p.m. (eastern). Go here to register to participate.
HHS – Monoclonals and More: Issues and Opportunities with Early COVID-19 Treatment Options – November 12
HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution). Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation. For more information about the webinar and to register, go here.
CMS – COVID-19 Vaccines and Rural Communities – November 15
CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas. Go here for further information about the webinar and to register to participate.
CDC – Antibiotic Prescribing and COVID-19 – November 18
The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern). Go here for information about the webinar, the presenters, and how to participate.