Federal Health Policy Update for Wednesday, January 19

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, January 19.  Some of the language used below is taken directly from government documents.

Public Health Emergency Declaration Renewed

  • HHS Secretary Xavier Becerra has renewed his department’s declaration of a public health emergency in response to the COVID-19 pandemic.  The renewal took effect on January 16 and extends the declaration for three months.  Find the declaration here.

Free COVID-19 Tests and Masks

  • Upon request, the federal government is now providing four free monthly home COVID-19 tests to every household.  Order those tests here.
  • The administration will make 400 million N95 respirators from the Strategic National Stockpile free to Americans. The N95 respirators will be available for the public to pick up at local pharmacies and health centers.  The masks will begin shipping this week and will start to become available late next week.  The notice is posted here.

White House

The White House has issued a fact sheet elaborating on several recent policy developments:

  • How individuals may get free COVID-19 tests delivered to their homes.
  • Additional information about the new requirement that health insurers must cover the cost of at-home COVID-19 tests.
  • The plan to provide more tests to schools.
  • Federal plans to establish more free testing sites and more surge testing sites.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter with Medicare reimbursement information.  This latest edition includes articles on vaccine access in long-term-care facilities; the 2022 annual update of the clinical lab fee schedule and lab services subject to reasonable charge payment; new and expanded flexibilities for Rural Health Centers and Federally Qualified Health Centers during the COVID-19 public health emergency; changes in Rural Health Center payments that took effect on January 1; and more.  Learn more in this week’s MLN Connects.
  • CMS has published a quarterly update of the national correct coding initiative (NCCI) procedure-to-procedure edits, version 28.1, which takes effect on April 1, 2022.  Find the update here.
  • CMS’s Center for Medicare and Medicaid Innovation (CMMI) has published a list of 2022 participants in its Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model, an advanced alternative payment model (APM) under its quality payment program.  Learn more about the program here and go here for a downloadable file with a list of the program’s 2022 participants.
  • CMMI has published the annual report for its Comprehensive ESRD Care Model.  Learn more about the model here and go here for the annual report for the program’s performance year five.

Department of Health and Human Services

Health Policy Update

  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has announced the publication of the Trusted Exchange Framework and the Common Agreement (TEFCA).  Entities will soon be able to apply and be designated as Qualified Health Information Networks (QHINs), which will connect to one another and enable their participants to engage in health information exchange across the country.  TEFCA supports multiple exchange purposes critical to improving health care and has the potential to benefit a wide variety of health care entities. This flexible structure should enable stakeholders – such as health information networks, ambulatory practices, hospitals, health centers, federal government agencies, public health agencies, and payers – to benefit from TEFCA through improved access to health information. Individuals also will be able to benefit from TEFCA and seek access to their health information through entities that offer individual access services.  Learn more about TEFCA from this HHS news release and from the TEFCA web page.  Interested parties also can go here for information about webinars that will offer an overview of the program and its implications.
  • HHS and its Health Resources and Services Administration (HRSA) have announced the availability of $13 million in funding to increase access to behavioral health care services and address health inequities in rural America, including through evidence-based, trauma-informed treatment for substance use disorder.  Eligible applicants include entities such as Rural Health Clinics, federally recognized tribes, tribal organizations, and community- and faith-based organizations.  Learn more about the funding from this HHS news release and HRSA’s grant opportunity notice.  Applications are due by April 19.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals to serve as members of the U.S. Preventive Services Task Force.  Nominations are due March 15.  For further information, see this Federal Register notice.

Centers for Disease Control and Prevention

COVID-19

  • The CDC has updated its recommendations for isolation for people with COVID-19.  The updated guidance includes new recommendations for the duration of isolation for people with COVID-19 who are moderately or severely immunocompromised.  Find the updated guidance here.
  • The CDC has updated its consumer web page that describes the types of masks and respirators used to prevent the transmission of COVID-19.  The updated page describes the protection provided by available masks and respirators.  Find the updated page here.
  • The CDC has published research on racial and ethnic disparities in receipt of medications for the treatment of COVID-19 in the U.S. between March of 2020 and August of 2021.  Find the report here.

Health Policy Update

Food and Drug Administration

  • The FDA’s Center for Devices and Radiological Health has published its “Health of Women Program Strategic Plan.”  The plan presents a framework to further the FDA’s mission by protecting and promoting the health of women, strengthening regulatory science, and identifying and addressing current and emerging issues in medical device research and regulation for the health of all women.  To learn more about the plan, its purpose, and its priorities see this FDA statement and find the plan itself here.

FEMA

  • The administrator of the Federal Emergency Management Agency participated in a White House news briefing to outline steps FEMA is currently taking to support COVID-19 testing and health care providers serving large numbers of COVID-19 patients in the states.  Find a transcript of that briefing here.

Congressional Research Service

U.S. Preventive Services Task Force

  • The U.S. Preventive Services Task Force has invited public comment on its draft recommendations statement and draft evidence review on behavioral counseling to promote a healthy lifestyle in adults without cardiovascular risk factors.  While an independent, non-government body, the group was charged by the Affordable Care Act with making an annual report to Congress that identifies gaps in the evidence base for clinical preventive services and recommends priority areas that deserve further examination.  For information about the public comment period and links to the documents with the recommendations, go here.  Comments are due February 14.

Stakeholder Events

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Go here for a meeting agenda and information about registering for the virtual meeting.

Federal Health Policy Update for Thursday, January 13

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, January 13.  Some of the language used below is taken directly from government documents.

Supreme Court

  • The Supreme Court has ruled that the administration’s vaccine mandate for health care workers will remain in effect while the mandate is challenged in the lower courts.  See the court’s ruling here.

White House

  • The White House has announced new efforts to protect children from COVID-19 and keep schools open.  The new measures include:
    • Sending more point-of-care and lab-based PCR tests to schools.
    • Deploying federal surge testing units at community testing sites to support free testing access for students, school staff, and families.
    • Connecting schools with COVID-19 testing providers to set up school testing programs.
    • Providing new training, resources, and materials.

Learn more from this White House fact sheet.

Medicare Payment Advisory Commission

MedPAC met today and voted on its recommendations for Medicare payment updates for the next fiscal year.  The recommendations adopted by the MedPAC commissioners are:

  • hospital inpatient payments – a 2.5 percent increase
  • hospital outpatient payments – a 2.0 percent increase
  • long-term-care hospital payments – a market basket increase and a productivity adjustment that together amount to an effective increase of approximately 2.0 percent
  • independent rehabilitation facility payments – a 5.0 percent reduction
  • skilled nursing facilities – a 5.0 percent reduction
  • home health services – a 5.0 percent reduction
  • physicians and primary care – an update in line with current law and retention of the 5.0 percent bonus opportunity for participations in alternative payment models
  • ambulatory surgery centers – a 2.0 percent increase and requirement that such facilities be required to file cost reports
  • hospice – an update in line with statute and to lower the aggregate cap 20 percent

MedPAC’s recommendations are advisory only and, while generally respected, are not binding on the administration and CMS.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS has released a proposed National Coverage Determination (NCD) decision memorandum explaining that it will cover FDA-approved monoclonal antibodies for the treatment of Alzheimer’s disease only through coverage with evidence development, which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.  The policy’s most immediate application will be to limit Medicare coverage for the new Alzheimer’s drug Aduhelm (aducanumab).  Learn more about this policy in this CMS news release and the decision memorandum.  Interested parties have 30 days to submit written comments and CMS says it will announce its final decision by April 11.
  • CMS has posted the latest edition of MLN Connects, its online newsletter with information about Medicare reimbursement issues.  This edition includes articles about new guidance for safe nursing home visitation, vaccine access in long-term-care facilities, a new billing code for administering remdesivir in outpatient settings, the application process for new medical residency slots, and more.  Learn more in the latest edition of MLN Connects.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the final annual reports for phase two of its initiative to reduce avoidable hospitalizations among nursing facility residents.  Go here to learn more about the program and find those annual reports.

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

MedPAC – January 14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 14.  Go here for a meeting agenda and information about virtual participation.

CMS – January 18

CMS administrator Chiquita Brooks-LaSure and her leadership team will hold a national stakeholder call on Tuesday, January 18 during which they will review their key 2021 accomplishments and share their goals for 2022.  Go here to register to join the call.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Go here for a meeting agenda and information about registering for the virtual meeting.

 

Federal Health Policy Update for Tuesday, January 11

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, January 11.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS has updated its FAQ for reconsideration requests involving Phase 4 and rural hospital payments.  Find the updated FAQ here.

Department of Health and Human Services

COVID-19

  • HHS announced that beginning January 15, individuals with private health insurance coverage who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the FDA will be able to have those test costs covered by their insurance.  Insurers will be required to cover eight free over-the-counter home tests per covered individual per month.  Over-the-counter test purchases will be covered in the commercial market without the need for a health care provider’s order or individualized clinical assessment and without any cost-sharing requirements such as deductibles, co-payments or coinsurance, prior authorization, or other medical management requirements.  Learn more about how this process will work from this HHS news release; a CMS explanation of how to get free tests; and an HHS FAQ.

Health Policy Update

  • HHS’s Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents.  Under the Affordable Care Act, certain group health plans and insurers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines.  Learn more about the updated guidelines in this HHS news release and the updated guidelines.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC), in collaboration with standards development organizations and health IT stakeholders, has released the Project US@ Technical Specification Final Version 1.0.  This new specification is a unified, cross-standards, health care specification that could be used across the health care industry for representing patient addresses (mailing, physical, billing, and more) to improve patient matching. Patient matching, and specifically how patient addresses are represented, has long been viewed as a critical component of nation-wide interoperability and the nation’s health IT infrastructure.  ONC encourages state and federal agencies, public health organizations, payers, health IT developers, research organizations, health care providers, and others to consider adopting and implementing the final specification.  Learn more from this HHS news release and see the Project US@ web page to learn more about the project and for a link to the final technical specification.
  • HHS’s Office of Minority Health has extended to March 11 the deadline for nominations for delegates for the Center for Indigenous Innovation and Health Equity Tribal Advisory Committee.  Learn more from this Federal Register notice.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation has published a new issue brief, “Access to Preventive Services without Cost-Sharing:  Evidence from the Affordable Care Act,” that summarizes the Affordable Care Act’s preventive services provisions for private health coverage, Medicare, and Medicaid; provides updated estimates of the number of people benefiting from these provisions nationally; and examines evidence on trends in utilization of preventive services and outcomes since the Affordable Care Act’s preventive services coverage requirements went into effect.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy Update

  • Medicare will begin funding 1000 new medical residency positions beginning in FY 2023.  For information about how to apply for those positions, go here (and scroll down to “Section 126: Distribution of Additional Residency Positions”).  The deadline for applications for FY 2023 positions is March 31, 2022.
  • CMS has issued a proposed rule to revise Medicare Advantage Part C and Medicare Prescription Drug Benefit Part D regulations to implement changes involving marketing and communications, past performance, star ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions.  This proposed rule also would revise regulations addressing dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.  According to CMS, the proposed rule would lower out-of-pocket prescription drug costs for beneficiaries with Medicare Part D; improve price transparency and market competition; improve beneficiaries’ experiences with Medicare Advantage and Part D, with a strong emphasis on individuals who are dually eligible for Medicare and Medicaid; and hold Medicare Advantage and Part D plans to a higher standard in offering benefits and improve health equity in the programs.”  Learn more about the proposed rule from this CMS news release, a CMS fact sheet describing the rule in greater detail, and the proposed rule itself.  Interested parties have until March 7 to submit written comments.
  • Included in this same proposed rule is a request for comments as CMS assesses the impact of Medicare Advantage organizations’ prior authorization requirements for patient transfer on a hospitals’ ability to effectively manage resources and provide appropriate and timely care during a public health emergency.  Learn more about this request from this excerpt from the proposed rule.
  • CMS has informed nursing home operators that it will introduce data on nursing home staff turnover and weekend staffing to the Care Compare website in January of 2022 and the Nursing Home Five Star Quality Rating System in July 2022.  Learn more, including the rationale for including this information, from this memo from CMS to nursing home operators.
  • CMS’s Center for Medicare and Medicaid Innovation (CMMI) has published a list of the initial participants in its Kidney Care Choices Model, which was launched on January 1.  Learn more about the model here and find a list of the participants here.
  • CMMI has published evaluation and savings reports for four of the 13 states that participate in its Financial Alignment Initiative for Medicare-Medicaid Enrollees program.  Go here to learn about the program and find links to the reports.

COVID-19

Centers for Disease Control and Prevention

  • The CDC has updated its guidance on the differences between quarantine and isolation and who needs to quarantine or isolate, and for how long, based on different types of exposure to or infection with COVID-19.  Find this update here.
  • The CDC has posted new information about the need for COVID-19 vaccinations and boosters for those who are immunocompromised, including advice that some such people receive an additional primary vaccine before receiving a booster shot.  Find that guidance here.
  • The CDC has updated its COVID-19 vaccination recommendations for children and teens.
  • It is already known that COVID-19 infection is associated with worsening of diabetes symptoms and that persons with diabetes are at increased risk for severe COVID-19.   It also is believed that COVID-19 may induce newly diagnosed diabetes.  Now, the CDC has published new research indicating that persons under the age of 18 with COVID-19 were more likely to receive a new diabetes diagnosis more than 30 days after infection than were those without COVID-19 and those with pre-pandemic acute respiratory infections.  Go here to see the CDC’s report.
  • The CDC has updated its information about possible side effects from COVID-19 vaccines.
  • The CDC has published new research that finds that the estimated effectiveness of two doses of Pfizer vaccine against multisystem inflammatory syndrome in children (MIS-C) was 91 percent.  Among critically ill COVID-19 MIS-C patients requiring life support, all were unvaccinated.  Go here to see the CDC’s report.
  • The CDC has updated its infection prevention and control assessment tool for nursing homes preparing for COVID-19.
  • The CDC has posted updated information about Operation Expanded Testing, which seeks to increase access to testing nationwide, especially for communities that have been disproportionately affected by the COVID-19 pandemic.  The program provides no-cost testing to child care centers, K-12 schools, historically black colleges and universities, under-resourced communities, and congregate settings, such as homeless shelters, domestic violence and abuse shelters, non-federal correctional facilities, and other qualified sites.  The program can perform millions of tests through July 1, 2022, with contractor-provided laboratory services that include specimen collection supplies, shipping materials, laboratory testing, and results reporting.  Recipient sites contribute staff to collect specimens.  Learn more from this CDC resource.
  • The CDC is seeking nominations for individuals to serve on its Advisory Committee on Breast Cancer in Young Women.  Nominations are due February 28.  Learn more from this Federal Register notice.

Food and Drug Administration

  • The FDA has amended the emergency use authorization for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.  The previous standard was six months.  Learn more from this FDA news release.

Medicare Payment Advisory Commission (MedPAC)

  • The Government Accountability Office is accepting nominations for individuals to serve as MedPAC commissioner beginning in May of this year.  Letters of nomination and resumes are due February 11.  Learn more from this Federal Register notice.

Congressional Research Service

  • A new Congressional Research Service study, “Occupational Safety and Health Administration (OSHA):  COVID-19 Emergency Temporary Standards (ETS) on Health Care Employment and Vaccinations and Testing for Large Employers,” reviews OSHA’s authority to propose such a requirement, its promulgation of the requirement, legal action in response to its release, and its eventual withdrawal.  Find the study here.

Stakeholder Events

CDC – Clinical Outreach Communication Activity – January 12

Through its Clinical Outreach Communication Activity program, the CDC will hold a webinar on “What Clinicians Need to Know About the New Oral Antiviral Medications for COVID-19” on Wednesday, January 12 at 2:00 p.m.  Go here to learn more about the webinar, its purpose, the individuals who will be presenting, and how to participate.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Go here for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

Federal Health Policy Update for Monday, January 3

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, January 3.  Some of the language used below is taken directly from government documents.

The White House

  • President Biden has issued a memorandum to the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Federal Emergency Management Agency on maximizing assistance to respond to COVID-⁠19.  Among other things, the memorandum calls for FEMA to provide emergency and disaster assistance, to establish or expand COVID-19 testing sites at the request of state governments, and to underwrite the full costs it incurs in such efforts.  Learn more from the memorandum.
  • The White House has posted a transcript of the December 29 press briefing given by its COVID-19 response team and public officials.

Provider Relief Fund

  • The Provider Relief Fund reporting portal is now open for reporting period 2 and will remain open through March 31, 2022.  Go here for more information about what organizations do and do not need to report and how to do so.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS’s Center for Medicare and Medicaid Innovation has a “Most Favored Nation Model” that seeks to test a way to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other, similar countries. The program was schedule to begin in 2021 but was delayed when a federal court issued a preliminary injunction against that implementation.  Between the court’s ruling and stakeholder feedback, CMMI has decided to withdraw its Most Favored Nation Model and did so in this Federal Register notice.  Additional information can be found on CMMI’s Most Favored Nation Model web page.

Department of Health and Human Services

Health Policy Update

  • HHS is working with states to promote access to Medicaid services for people with mental health and substance use disorder crises by giving states a new option for supporting community-based mobile crisis intervention services for individuals with Medicaid through newly available federal funds.  The American Rescue Plan grants CMS new authority to provide states with additional resources and tools to enhance these programs, including additional federal funding to states for qualifying mobile crisis intervention services for three years.  This new Medicaid option also offers flexibility for states to design programs that work for their communities, allowing states to apply for this new option under several Medicaid authorities.  Learn more from this HHS news release and this guidance letter CMS has sent to state Medicaid directors.
  • HHS has published a Notice of Benefit and Payment Parameters 2023 Proposed Rule that seeks to make it easier for consumers to find affordable, comprehensive health coverage.  Among other steps, the proposed rule seeks to advance standardized plan options, implement network adequacy reviews, strengthen access to essential community providers, and prohibit discriminatory practices.  Learn more from this HHS news release, this HHS fact sheet, and the proposed rule itself.  Interested parties have until January 27 to submit formal written comments.

Occupational Safety and Health Administration (OSHA)

  • In June, OSHA adopted a “Healthcare Emergency Temporary Standard” to protect workers from COVID-19 in settings where they provide health care or health care services, doing so with the expectation that this standard would be formalized in regulation within six months.  Now, OSHA has announced that while the regulation still has not been finalized it “…will vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19” while modifying certain other aspects of the standard.  Learn more about the standard and the ways in which the agency intends to enforce and modify it in this OSHA statement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to expand the use of a single booster dose to include use in individuals 12 through 15 years of age; to shorten the time between the completion of the original Pfizer vaccine regimen and a booster dose to at least five months; and to allow for a third primary series dose for certain immunocompromised children five through 11 years of age.  Learn more from this FDA news release.
  • The FDA has updated its EUA for COVID-19 convalescent plasma by placing new limits on its use.  See the announcement here and the revised EUA here.
  • The FDA is inviting industry organizations to participate in the selection of non-voting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health by nominating such individuals in writing.  The agency also seeks nominations for non-voting industry representatives to serve on certain device panels.  Learn more from this Federal Register notice.  The deadline for nominations is February 2.

Stakeholder Events

HHS Office of the Assistant Secretary for Preparedness – January 6

HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and Project ECHO will hold a “COVID-19 Clinical Rounds: A Peer-to-Peer Virtual Community of Practice” event on Thursday, January 6 at 12:00 (eastern).  COVID-19 Clinical Rounds are resource webinars intended for consultant physicians involved in critical care practice, fellows, residents, pharmacists, nursing staff, nurse practitioners, physician assistants, respiratory therapists, and allied health staff.  Go here to register for the January 6 event and find recordings of previous events here.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

Federal Health Policy Update for Monday, December 6

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, December 6.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to the Department of Health and Human Services, Department of Labor, Department of the Treasury, and federal Office of Personnel Management in response to those agencies’ publication of a second regulation describing how the No Surprises Act will be implemented. In its letter NASH focuses on problems with the manner in which providers will be required to prepare good-faith estimates for those seeking care without benefit of insurance, the regulation’s Independent Dispute Resolution process, and the manner in which the regulation addresses resolving fee disputes between providers and patients.  NASH raises concerns about all of these processes, suggests better approaches to addressing them, and asks the federal agencies to suspend enforcement of the new requirements while they consider ways to improve the current approach to implementing the surprise billing law that was enacted late last year.  Go here to read NASH’s comment letter.

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has announced that it will require states to cover COVID-19 vaccine counseling during which health care providers talk to families about the importance of vaccines for children. Under this policy CMS will now consider certain COVID-19 vaccine counseling visits for children and youth to be COVID-19 vaccine administration for which state expenditures can be federally matched at 100 percent through the last day of the first quarter that begins one year after the end of the COVID-19 public health emergency.  CMS will match COVID-19 vaccine counseling-only visits at the 100 percent federal match rate only when they are provided to children and youth under age 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.  Learn more from this CMS news release.
  • CMS has announced a series of steps it will take to encourage Medicare beneficiaries to receive COVID-19 vaccines. Read about these steps in this CMS news release.

Health Policy Update

Department of Health and Human Services

Health Policy Update

  • A new HHS report found a significant increase in the use of telehealth during the COVID-19 pandemic, with specialists like behavioral health providers seeing the highest telehealth utilization relative to other providers. The report found that the share of Medicare visits conducted through telehealth in 2020 increased 63-fold, from approximately 840,000 in 2019 to 52.7 million.  States with the highest use of telehealth in 2020 included Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut while states with the lowest use of telehealth that year were Tennessee, Nebraska, Kansas, North Dakota, and Wyoming. The report also identified trends in the kinds of services Medicare beneficiaries sought through telehealth.  Learn more from this HHS news release and go here to see the report itself.

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

CMS – Open Door Forum on No Surprises Act – December 8

CMS will host an open door forum to discuss provider requirements under the No Surprises Act on Wednesday, December 8 at 2:00 p.m. (eastern).  The forum will be held by conference call only and interested parties can dial into the event at 1-888-455-1397; the conference ID is 8604468.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  The two days of meetings will consist of four separate sessions.  For agendas for those sessions and information on how to register to participate, go here.

MACPAC – commission meeting – December 9-10

Members of the Medicaid and CHIP Payment and Access Commission will meet virtually on December 9 and 10.  To see the meeting agenda and register to participate, go here.

Federal Health Policy Update for Wednesday, December 1

The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1.  Some of the language used below is taken directly from government documents.

Omicron Variant

  • The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil.  Learn more from this CDC news release.

Health Care Employee Vaccine Mandate

COVID-19

  • A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6.  Find the court’s ruling here.  The ultimate ruling will be made by a higher court.

No Surprises Act

  • CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1.  Go here for a link to a zip file of those documents.
  • A reminder:  stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government.  Find that guidance here.
  • CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes:  one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements.  Find the revised blanket waivers document here.

Health Policy Update

  • CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs.  Learn more about what CMS seeks in this Federal Register notice.  Stakeholder comments are due in 60 days.
  • CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model.  That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries.  After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation.  Learn more from this CMS announcement.
  • CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world:  “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
  • CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters.  This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more.  Go here for the new MLN Connects.

Department of Health and Human Services

Health Policy Update

  • HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program.  The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.”  The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training.  Learn more from this HHS news release and go here to find the new site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories.  Find that guidance here.
  • The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  Go here for an FDA fact sheet on the drug’s use.
  • The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant.  Find that statement here.

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.

Federal Health Policy Update for Monday, November 15

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, November 15.  Some of the language used below is taken directly from government documents.

The White House

Centers for Medicare & Medicaid Services – Final Guidance on Shared/Co-Located Hospital Spaces

  • In a memo to state survey agencies, CMS has published final guidance for the evaluation of compliance with the Medicare Conditions of Participation that address shared space and services for hospitals co-located with other hospitals or health care entities, updating guidance issued in May of 2019.  The revised guidance is shorter and less prescriptive and does not contain nearly as much detail as the 2019 draft.  Find it here.

Centers for Medicare & Medicaid Services

COVID-19

  • In a memo to state survey agencies, CMS has revised restrictions on nursing home visits, easing limits it introduced last year in an attempt to limit the spread of COVID-19.  Find the new guidance here.
  • A second CMS memo to state survey agencies on the subject of nursing homes suggests steps those agencies can take to address the backlog of facility complaint and recertification surveys that has amassed during the pandemic.  Find that memo here.

Health Policy Update

  • CMS has published the latest edition of MLN Connects, its online newsletter about Medicare reimbursement matters.  The new update has articles about CMS’s provider enrollment application fee for CY 2022, updates in the long-term hospital (LTCH) and inpatient rehabilitation facility (IRF) quality reporting programs for 2022, billing for durable medical equipment provided during inpatient stays, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released its Medicare Part A and Part B premiums for calendar year 2022.  The Part B increase is one of the largest in years, which CMS attributes to the possibility that it may be required to provide coverage for the use of the new Alzheimer’s treatment drug Aduhelm.  Learn more about 2022 Part A and Part B premiums and Medicare coverage changes in this CMS news release and an accompanying CMS fact sheet.
  • CMS has repealed a regulation adopted in January of this year titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and Necessary’” that established faster access for Medicare beneficiaries to recently authorized medical devices designated as breakthroughs by the FDA.  See the repeal notice and read CMS’s rationale for its action in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • HHS has withdrawn a policy that directed the FDA not to enforce pre-market review requirements for laboratory-developed tests.  The FDA also updated its policies regarding tests, including laboratory-developed tests, currently being offered prior to or without authorization as well as policies regarding the types of tests on which the FDA intends to focus its reviews in the future.  Go here to see the FDA announcement about this change and its future priorities and go here to read a statement from HHS Secretary Xavier Becerra outlining his rationale for the change.

National Institutes of Health

  • The NIH has enrolled the first participants in a study that will track up to 1000 children and young adults who previously tested positive for COVID-19 and evaluate the impact of COVID-19 on their physical and mental health over three years.  Learn more from this NIH announcement.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • In September of this year the Senate Finance Committee requested input on opportunities to enhance behavioral health care in the areas of strengthening the workforce; increasing integration, coordination, and access; ensuring parity between behavioral health and physical health care; furthering the use of telehealth; and improving access to behavioral health care for children and young people.  In its response to this request, MACPAC urges the committee to address the needs of adults and children enrolled in Medicaid and CHIP.  In addition, it stresses the need to address barriers to care that result in disparities in access to care and behavioral health outcomes for Black, Hispanic, and Asian American beneficiaries, people with disabilities, and those living in rural areas.  Go here to see MACPAC’s full response.

Stakeholder Events

CMS – Hospital/Quality Imitative Open Door Forum – November 17

CMS will hold a Hospital/Quality Initiative Open Door Forum on Wednesday, November 17 at 2:00 p.m. (eastern).  The forum will address a number of issues, including the CY 2022 hospital outpatient prospective payment system and ambulatory surgical center payment system final rule, outpatient payments, pass-through drugs and devices, ambulatory surgical center payments, hospital price transparency, and the Radiation Oncology Model.  This forum will be held by conference call.

To participate, dial 1-888-455-1397 and use conference passcode 8604468

HHS/Center for Medicare and Medicaid Innovation – November 18

On Thursday, November 18 HHS’s Center for Medicare and Medicaid Innovation will host a webinar listening session at 1:00 p.m. (eastern) as a follow-up to the release of its recently published document “Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade.”  The listening session will be an opportunity for stakeholders to share with CMS leaders their perspectives on how to execute the agency’s strategic vision.  Register for the event and find more information here.

CDC/NIOSH – Mental Health of the Health Care Workforce – November 18

On Thursday, November 18 the CDC’s National Institute for Occupational Safety and Health (NIOSH) will host a virtual event with NIOSH director Dr. John Howard, Surgeon General Dr. Vivek Murthy, and other national experts from labor and medicine on the mental health of the nation’s critical health workforce.  Go here to learn more about the participants and the subjects they plan to address and go here 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.

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

Federal Health Policy Update for Wednesday, November 10

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, November 10.  Some of the language used below is taken directly from government documents.

The White House

  • The White House announced that it will spend $785 million in American Rescue Plan funding to support community-based organizations building vaccine confidence across communities of color, rural areas, and low-income populations; bolster the efforts of Tribal communities leading the way in mitigating the spread of the virus; expand public health systems’ ability to respond to the needs of people with disabilities and older adults who have been among the highest risk for infection or death from COVID-19; and continue its mission to build a more diverse and sustainable public health workforce, including a new apprenticeship program that will train thousands of our COVID-19 community health workers and prepare them for long-term careers in public health.  Learn more from a White House fact sheet about the initiative.
  • The president has issued a memo to the secretary of the Department of Homeland Security and the administrator of the Federal Emergency Management Agency (FEMA) directing them to continue reimbursing states for 100 percent of the cost of using their national guard units in their response to the COVID-19 pandemic through April 1, 2022.  See that memo here.
  • The White House has posted a transcript of the November 10 press briefing given by its COVID-19 response team and public officials.  Go here for the slides presented during that briefing.

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 this Friday, November 12.

Department of Health and Human Services

COVID-19

  • HHS will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and improve Americans’ access to them.  HHS will use these funds to ramp up U.S. domestic manufacturing capacity.  Learn more from this HHS announcement.
  • HHS will spend $143.5 million in American Rescue Plan money to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence, and address barriers to vaccination in their communities.  The funding will support two programs in which award recipients will develop regional and local partnerships to reach unvaccinated individuals, including pregnant women and people from underserved and high-risk communities, to help bolster COVID-19 vaccination efforts.  Learn more from this HHS news release.  Much of the funding has already been awarded but $10 million is still available, to be awarded on a competitive basis.  Learn more from this HHS funding notice.  Applications are due December 10.

Health Policy News

  • HHS’s Office on Women’s Health has announced that more than 200 hospitals are participating in the HHS Perinatal Improvement Collaborative, which will focus on improving maternal and infant health outcomes by reducing disparities.  Including hospitals from all 50 states, the collaborative will be the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.  Learn more about the program and find a list of the participating hospitals in this HHS announcement.

HHS/Center for Medicare and Medicaid Innovation

Next Thursday, November 18, the CMS Innovation Center (CMMI) will host a webinar listening session at 1 p.m. (eastern).  Register for that webinar and find more information here.

CMMI has requested stakeholder input on three specific questions and NASH intends to submit responses on behalf of its members.  To do so, we need to hear from you.  Please review the CMMI questions below and send us your written responses no later than the close of business this Friday, November 12.  If you prefer to share your responses to these questions via phone, we will be happy to schedule a call with you.

Questions from CMMI

  1. What is the greatest obstacle to participating in a CMS Innovation Center or other value-based, accountable care model, and how do you recommend the CMS Innovation Center alleviate this obstacle?
  2. CMS is currently exploring quicker, more actionable data, learning collaboratives, and payment and regulatory flexibilities. What else could the CMS Innovation Center do to support clinicians and help them be successful in models?
  3. How can CMMI better incorporate patient needs and goals into models? How should the impacts of value-based care on patients be measured?

NASH staff will compile member responses and submit them to CMMI prior to next week’s listening session.

Centers for Medicare & Medicaid Services

COVID-19

  • Last week CMS held a webinar to explain the new federal regulation that mandates COVID-19 vaccines for all health care workers and others employed by provider organizations regulated under Medicare’s conditions of participation.  Learn more about the regulation from this video of the webinar and the slides presented during the event.  CMS also has posted an infographic about the requirement.
  • The Surgeon General has released a new community toolkit to help individuals, health care professionals and administrators, teachers, school administrators, librarians, and faith leaders to understand, identify, and stop the spread health misinformation in their communities.  Learn more from this HHS announcement and go here to see the toolkit.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

Stakeholder Events

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.

Federal Health Policy Update for Monday, October 25

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, October 25.  Some of the language used below is taken directly from government documents.

NASH Advocacy:  MedPAC and Safety-Net Hospitals

On the heels of a recent meeting of the Medicare Payment Advisory Commission (MedPAC) during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to addressing that matter.  In the letter, NASH suggests that MedPAC urge Medicare to look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  Go here to see NASH’s letter to MedPAC.  In response to this letter, MedPAC scheduled a meeting with NASH to discuss this concept.

NASH Advocacy:  Surprise Billing Regulation

Representatives Suozzi (D-NY), Wenstrup (R-OH), Ruiz (D-CA), and Bucshon (R-IL) are leading a bi-partisan congressional sign-on letter to HHS Secretary Becerra and others, urging the administration to revise the Surprise Billing, Part II interim final rule’s (IFR) implementation of the independent dispute resolution (IDR) process.

The letter states that

…we urge you to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all of the factors outlined in the statute without disproportionately weighting one factor.

NASH is listed among the supporters of this letter.

Action required:  NASH members should contact their House members today to ask them to sign on to the Suozzi-Wenstrup-Ruiz-Bucshon letter to support the successful implementation of Congress’s surprise billing ban.  The deadline for representatives to sign onto the letter is this Friday, October 29.

If you would like more information about the letter or if you need contact information for your representatives, contact Kate Finkelstein.

Provider Relief Fund:  Deadline for Submission is Tuesday, October 26

  • The Health Resources and Services Administration (HRSA) will accept applications for $25.5 billion in health care relief funds until October 26.  Go here for further information.
  • HRSA has modified some of the terms for applying for assistanceAll applicants must complete the first step of the application process (i.e., submitting their Tax Identification Number (TIN) and associated information for Internal Revenue Service (IRS) validation no later than October 26, 2021 at 11:59 PM EST.  The required IRS validation that occurs after completion of the first step may take a few days.  If an applicant submits their TIN for validation by the October 26, 2021 deadline and that TIN is subsequently validated by the IRS, the applicant will have until November 3, 2021 at 11:59 PM EST to complete and submit their application.
  • The Provider Relief Fund FAQ has been updated with seven modified or new questions on pages 4, 9, 10 (two questions), 37, and 58 (two questions); all are dated 10/20/2021.  Entities that have received Provider Relief Funds in the past and/or intend to apply for Phase 4 funds should review these changes carefully.

The White House

  • In anticipation of the FDA’s independent advisory committee meeting on October 26 and the CDC’s independent advisory committee meeting on November 2-3, the administration has unveiled a plan to ensure that if a vaccine is authorized for children ages 5-11 it is quickly distributed and made conveniently and equitably available to families across the country.  Learn more from this White House fact sheet.
  • The White House has posted transcripts of the October 20 and October 22 press briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued guidance to states about the statutory requirement for them to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs.  This coverage includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.  Find a news release about the guidance here and find the guidance itself here.
  • CMS has posted a new edition of MLN Connects, its online newsletter.  This latest edition includes features on new/modifications of the place of service codes for telehealth, a prescriber’s guide to Medicare prescription drug opioid policies, and more.  Go here to find these and other items.
  • In a separate, special edition of MLN Connects, CMS presents new Medicare rates and billing information for Moderna and Johnson & Johnson booster vaccines.
  • The CMS Innovation Center has published a document that shares its strategic direction for the coming years.  Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten.  Find it here.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the fourth evaluation report and performance year 5 (2020) financial and quality results for its Next Generation ACO Model.  Find the report by going here and scrolling down to “Performance Year 5 (2020 (XLS).”
  • CMS’s “Medicare & You” handbook is now available in Chinese, Korean, and Vietnamese.  Go here for the agency’s announcement and links to the new handbooks.

Department of Health and Human Services

Health Policy News

  • HHS is awarding $797.5 million in American Rescue Plan funding to support survivors of domestic violence and sexual assault and their children.  The funds will cover COVID-19 testing, vaccines, mobile health units, and other support for domestic violence services programs and increase support for sexual assault service providers and culturally specific services.  Learn more about the new spending and how it will be distributed in this HHS news release and additional program resources.
  • HHS proposes repealing two final rules:  “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register of January 14, 2021, maintaining that “…they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.”  Learn more about the rules that would be repealed and HHS’s rationale for doing so in this Federal Register notice.

Centers for Disease Control and Prevention

  • The CDC has taken a series of actions to address COVID-19 booster vaccines, deciding that:
    • The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
    • The use of a single booster dose of the Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines may be use as a booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.  This is now being referred to by many as “mixing and matching.”
    • A single booster dose of the Pfizer vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Stakeholder Events

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters – October 26

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how 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.

Innovation Center Unveils Blueprint

The CMS Innovation Center has published a document that shares its strategic direction for the coming years.

Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten:

  • Drive Accountable Care – increase the number of people in a care relationship for quality and total cost of care.
  • Advance Health Equity – embed health equity in every aspect of CMS Innovation Center models and increase focus on underserved populations.
  • Support Care Innovation – leverage a range of supports that enable integrated, person-centered care such as actionable, practice-specific data, technology, dissemination of best practices, peer-to-peer learning collaborations, and payment flexibilities.
  • Improve Access by Addressing Affordability – pursue strategies to address health care prices, affordability, and reduce unnecessary or duplicative care.
  • Partner to Achieve System Transformation – align policies and priorities across CMS and aggressively engage payers, purchasers, providers, states, and beneficiaries to improve quality, to achieve equitable outcomes, and to reduce health care costs.

In addition, the document summarizes the lessons the CMS Innovation Center has learned over the past ten years, outlines future approaches to assessing the agency’s impact, and presents an implementation strategy for the coming years.

Learn more about what the CMS Innovation Center has in mind for providers, payers, and patients in the agency’s new document Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade and find a summary of the document here.