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Federal Health Policy Update for Monday, January 24

The following is the latest health policy news from the federal government as of 3:00 p.m. on Monday, January 24.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • The reconsideration window for Provider Relief Fund Phase 4 payments and American Rescue Plan rural hospital payments will open on February 1, 2022, at which time providers will be able to request reconsideration of their payments.  This process is intended only for providers that believe their payment was not calculated correctly.  They will not have an opportunity to submit an application if they missed a deadline; will not be able to revise or correct their original application; and will not be able to request reconsideration that would require a change to payment methodology or policy.  Learn more from this Provider Relief Fund web page.

White House

Centers for Medicare & Medicaid Services

COVID-19

Department of Health and Human Services

COVID-19 Update

Health Policy Update

  • HHS has awarded $6.6 million through the Title X family planning program to address the need for family planning services where restrictive laws and policies have affected access to reproductive health services.  These competitively awarded grants were made to entities in seven states.  Learn more about the program, how the funding will be used, and to whom it was awarded from this HHS news release.
  • In support of this objective, HHS has launched an agency-wide task force, the HHS Reproductive Healthcare Access Task Force, that consists of senior-level HHS officials who have been designated by their respective agencies to identify and coordinate activities across the department to protect and bolster access to essential sexual and reproductive health care, including implementation of activities identified in the White House National Strategy on Gender Equity and Equality.  The working group activities will focus on advancing quality, access, and equity for reproductive health, rights, and justice and include coordinating federal interagency policy-making, program development, and outreach to address barriers affecting individuals and communities seeking reproductive health care.  Learn more about the work the task force is expected to undertake from this HHS news release and from this HHS statement.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has released a Request for Information (RFI) seeking input from the public on electronic prior authorization standards, implementation specifications, and certification criteria that could be adopted within the ONC Health IT Certification Program.  Responses to this RFI may be used to inform potential future rulemaking to better enable providers to interact with health care plans and other payers for the automated, electronic completion of prior authorization tasks.  Learn more from this HHS news release and the RFI itself.  Stakeholder comments are due March 25.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has published a data brief on the most frequent reasons for emergency department visits in 2018.  Find it here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.   Recent data shows that these treatments are highly unlikely to be active against the omicron variant.  Learn more from this FDA statement.
  • The FDA has taken two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.  Those actions are:
    • The agency expanded the approved indication for remdesivir to include its use in adults and pediatric patients (12 years of age and older who weigh at least 88 pounds) with positive results of direct COVID-19 testing, are not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
    • It revised its emergency use authorization for remdesivir to authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, who have tested positive for COVID-19, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization of death.

Learn more from the following resources:

– an FDA news release;

– revised prescribing information for remdesivir;

– the revised emergency use authorization for the drug; and

– a revised FDA FAQ on remdesivir.

  • The FDA has updated its device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment/specimen collection category on the device shortage list.  The list previously included sodium citrate (light blue top) tubes only.  The device shortage list reflects the categories of devices the FDA has determined to be in short supply at this time.  The FDA has published an FAQ explaining the shortage and its decision.

National Institutes of Health

  • COVID-19 was initially identified as a respiratory virus but it can affect the entire body, including the nervous system, and this has implications for patients with long COVID, according to the NIH.  Learn more from this NIH news release.
  • COVID-19 vaccination does not affect the chances of conceiving a child, according to a study of more than 2000 couples that was funded by the National Institutes of Health.  Researchers found no differences in the chances of conception if either male or female partner had been vaccinated, compared to unvaccinated couples, but it did find that couples had a slightly lower chance of conception if the male partner had been infected with COVID-19 within 60 days before a menstrual cycle, suggesting that COVID-19 could temporarily reduce male fertility.  Learn more from this NIH news release.
  • Survey data of more than 3000 adolescents ages 11-14 recorded before and during the early months of the COVID-19 pandemic in 2020 found that supportive relationships with family and friends and healthy behaviors, like engaging in physical activity and better sleep, appeared to shield against the harmful effects of the pandemic on adolescents’ mental health.  Learn more from this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has posted a summary of its January 21-22 public meetings and provided links to the presentations made during those meetings.  Find them here.

Congressional Budget Office (CBO)

Stakeholder Events

NIH National Institute of Nursing Research – January 25

NIH’s National Institute of Nursing Research, which supports basic and clinical research that seeks to establish a scientific basis for the care of individuals, will hold an open session of its National Advisory Council for Nursing Research on January 25 at 11:00 a.m.  For a meeting agenda and information on how to view the meeting, go here.

 

 

Federal Health Policy Update for Thursday, January 6

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

Provider Relief Fund

The White House

Department of Health and Human Services

COVID-19 Hospital Data Reporting Requirements

  • HHS has written to health care providers to inform them of changes in its COVID-19 hospital data reporting requirements guidance; it has suspended reporting on some data elements and added some new ones.  The letter summarizes the changes, lists dates and times for webinars to learn about and ask questions about the changes, and offers telephone numbers and emails for support.  Find the letter here and find the revised reporting requirements here; changes in those requirements are highlighted.  HHS provided a preview of these changes to state officials; find its presentation to the states here.

COVID-19

  • HHS has amended a past COVID-19-related emergency declaration to authorize licensed pharmacists and pharmacy interns in good standing to order and administer flu vaccines in states in which they are not currently licensed and for such individuals to have liability protection under the Public Readiness and Emergency Preparedness (PREP) Act.  See the amended order in this Federal Register notice.

Health Policy Update

  • HHS’s Health Services and Resources Administration (HRSA) offers a number of funding opportunities with application deadlines in the coming weeks.  Go here to learn more about the various programs, what they offer, who can apply, and when applications are due.

Centers for Medicare & Medicaid Services

Health Policy Update

  • CMS has issued guidance to states and health insurers on state external review processes regarding requirements in the No Surprises Act, the federal surprise medical billing law that took effect on January 1.  See that guidance here.
  • CMS has published the latest edition of MLN Connects, its online newsletter with information about Medicare reimbursement issues.  The new issue includes items about changes in how Medicare Advantage plans will submit claims for monoclonal antibody treatments, the updated ambulatory surgical system payment system, a revised enrollment application for Medicare-covered opioid treatment, and more.  Go here to see the latest edition of MLN Connects.
  • CMS is seeking nominations for individuals to serve on several of its technical panels:  its technical expert panel for the Measurement Gaps and Measure Development Priorities for the Skilled Nursing Facility Value-Based Purchasing Program; for the CMS Quality Measure Development Plan and Quality Measure Index; and for its Dialysis Facility Quality of Patient Care Star Ratings Technical Expert Panel.  All of the nominations are due in the next few weeks.  Go here for further information about the individual panels, project summaries, and nomination criteria and deadlines.

Centers for Disease Control and Prevention

  • The CDC has updated its recommendation for when many people should receive a booster shot, shortening the interval from six months to five months for people who received the Pfizer vaccine.  This means that people can now receive an mRNA booster shot (Pfizer or Moderna) five months after completing their Pfizer primary series.  The booster interval recommendation for people who received the Johnson and Johnson vaccine (two months) and the Moderna vaccine (six months) has not changed.  Learn more from this CDC news release.
  • The CDC has endorsed its Advisory Committee on Immunization Practices’ recommendation to expand eligibility of booster doses to those 12 to 15 years old.  The CDC now recommends that adolescents ages 12 to 17 years old should receive a booster shot five months after their initial Pfizer vaccination series.  Find that announcement here.
  • The CDC now recommends that moderately or severely immunocompromised children between five and 11 years of age receive an additional primary dose of vaccine 28 days after their second shot.  At this time, the CDC has authorized only the Pfizer vaccine for this age group.  Learn more from the same CDC news release.
  • The CDC has updated its general guidance on COVID-19 vaccines and boosters for people who are moderately or severely immunocompromised.
  • The CDC has posted an explanation of why it has shortened its isolation and quarantine recommendations for individuals who are asymptomatic and mildly ill with COVID-19.  See the explanation here and the revised recommendations here.
  • The CDC has updated its overview and safety information about the Pfizer COVID-19 vaccine.
  • The CDC has updated its guidance on when people should be tested for COVID-19, when they do not need to be tested, and what they should do based on the results of such tests.
  • The CDC has published research on severe outcomes from COVID-19 among people who completed a primary vaccination regimen.  The research found that risk factors for severe outcomes included age 65 years or older, an immunosuppressed state, and six other underlying conditions.  All persons with severe outcomes had at least one risk factor; 78 percent of persons who died had at least four.  Go here to see the CDC’s report.

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for albuterol sulfate inhalation solution, which is used for the relief of bronchospasm in patients two to 12 years of age with asthma.  This preparation is sometimes used in the treatment of COVID-19.  See the FDA announcement of this approval here and technical information about albuterol sulfate here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • The Government Accountability Office (GAO) is now accepting nominations for individuals to serve as MACPAC commissioners.  Learn more from this Federal Register notice.  Nominations are due by January 27.
  • MACPAC has published the new issue brief “Medical Loss Ratios in Medicaid Managed Care,” which provides an overview of federal capitation rate setting standards and specific guidance regarding the medical loss ratio for Medicaid managed care plans and describes variations among the states that employ Medicaid managed care.  Find it here.

Stakeholder Events

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, 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 27

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, December 27.  Some of the language used below is taken directly from government documents.

Surprise Medical Billing Law Implementation Update

  • CMS has published an FAQ about the implementation of regulations governing the No Surprises Act, the surprise medical billing law enacted late last year.  The FAQ specifically addresses providers’ roles and responsibilities in developing the good-faith price estimates established by the law.  Find the FAQ here.

The White House

Provider Relief Fund

Centers for Medicare & Medicaid Services

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter that presents information about Medicare reimbursement matters.  The latest edition includes articles about updated billing instruction changes that take effect on January 1 for the hospital outpatient prospective payment system, coding changes for pneumonia vaccines, an increase in the FQHC base rate, and an update on COVID-19 vaccine access in long-term-care facilities.  Find these items and more in the latest edition of MLN Connects.
  • CMS has published its Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) final rule.  This rule establishes methodologies for adjusting the DMEPOS fee schedule using information from the Medicare DMEPOS competitive bidding program for items furnished on or after the effective date specified in this final rule or the date immediately following the duration of the emergency period described in the Social Security Act, whichever is later.  Learn more from this CMS fact sheet and the final rule itself, which takes effect in 60 days.

COVID-19

Department of Health and Human Services

COVID-19

  • HHS’s Office for Civil Rights has issued guidance tied to legal standards and best practices for improving access to COVID-19 vaccine programs and ensuring non-discrimination on the basis of race, color, and national origin.  The new guidance seeks to ensure that entities covered by civil rights laws understand their obligations under provisions of the Civil Rights Act of 1964 and the Affordable Care Act that require federally assisted health care providers and systems to ensure fair, equitable access to vaccines and boosters.  Learn more from this HHS news release and from the guidance itself.

Health Policy Update

  • HHS has announced the availability of $48 million in American Rescue Plan funding for community-based organizations to expand public health capacity in rural and tribal communities through health care job development, training, and placement.  Successful applicants will be able to use this funding to address workforce needs related to the long-term effects of COVID-19, health information technology needs, and other workforce issues.  Learn more from this HHS news release and from HHS’s official grant opportunity listing.  The deadline for applications is March 18.
  • The Healthcare Cost and Utilization Project of HHS’s Agency for Agency for Healthcare Research and Quality (AHRQ) has posted the new Statistical Brief “Overview of Major Ambulatory Surgeries Performed in Hospital-Owned Facilities, 2019.”
  • HHS has released the annual update of its “National Plan to Address Alzheimer’s Disease.”  Find an announcement about the report and a summary here and find the report itself here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has issued emergency use authorization (EUA) for the first oral treatment for COVID-19:  the Pfizer drug Paxlovid, which is for adults and pediatric patients at least 12 years of age and 88 pounds who are at high risk for progression to severe COVID-19, including hospitalization or death.  The drug should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.  Learn more from the following resources:
  • Shortly thereafter the FDA issued an EUA for another treatment for COVID-19:  Merck’s molnupiravir, which is a treatment for mild-to-moderate COVID-19 in adults with COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.  Molnupiravir should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset and is not authorized for use in patients younger than 18 years of age, for pre-exposure or post-exposure prevention of COVID-19, or for initiation of treatment in patients hospitalized due to COVID-19.  Learn more from the following resources:
  • The FDA updated its “SARS-CoV-2 Viral Mutations:  Impact on COVID-19 Tests” web page with new information on the COVID-19 omicron variant and the impact of that variant on antigen diagnostic tests.  The update also revises the FDA’s recommendations for clinical laboratory staff and health care providers and shares information about the impact of the omicron variant on molecular diagnostic tests.  Find the updated information here.
  • The FDA and HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) have released a joint statement on COVID-19 variants, including omicron, and how the variants may be associated with resistance to monoclonal antibodies.  The statement explains that

Circulating SARS-CoV-2 viral variants, including Omicron, may be associated with resistance to monoclonal antibodies.  Health care providers should review the Antiviral Resistance information in the Healthcare Provider Fact Sheet for each authorized therapeutic for details regarding specific variants and resistance.

The statement also explains that

FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1).  These data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant.  Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant.  Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC.  Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun.  An additional 300,000 doses of sotrovimab will be available for distribution in January.

Find the complete statement here.

  • The FDA has announced its first approval of a long-acting HIV prevention medication for use by adults and adolescents weighing at least 77 pounds who are at risk of sexually acquiring HIV.  Until now, the only FDA-licensed medications for HIV were daily oral pills.  Learn more from this NIH news release.

MACPAC (Medicaid and CHIP Payment and Access Commission)

MACPAC has published an issue brief that reviews the sources and uses of Medicaid section 1115 demonstration budget neutrality savings based on the agency’s review of spending reported in FY 2019 and discusses current policy issues related to section 1115 demonstration budget neutrality.  Learn more from the MACPAC issue brief “Section 1115 Demonstration Budget Neutrality.”

Federal Health Policy Update for Thursday, December 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, December 16.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS’s Health Resources and Services Administration (HRSA) is releasing $9 billion in phase 4 Provider Relief Fund grants.  Payments will average $58,000 for what HHS is calling “small” providers, $289,000 for medium providers, and $1.7 million for large providers.  Learn more about the release of these funds from this HHS news release and go here for an explanation of how the agency calculated the payments.  The remainder of Phase 4 funding is expected to be distributed in January.
  • HRSA has updated its FAQ for its provider relief programs:  the Provider Relief Fund and American Rescue Plan rural payments.  The updated FAQ includes new information about reporting on mergers and acquisitions, reporting patient metrics, reporting on state and federal tax credits, and more.  The 12 new and modified questions, all dated 12/9/2021, can be found on pages 3, 10, 14, 15, 18, 34, and 36 of the updated Provider Relief Fund FAQ.

The White House

  • The Biden administration has issued an executive order on “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.”  The portion of the executive order that addresses health care directs the Secretary of Health and Human Services to:
    • continue to design and deliver new, personalized online tools and expanded customer support options for Medicare enrollees;
    • strengthen requirements for maternal health quality measurement, including measuring perinatal quality and patient care experiences, and evaluating the measurements by race and ethnicity to aim to better identify inequities in maternal health care delivery and outcomes;
      to the maximum extent permitted by law, support coordination between benefit programs to ensure applicants and beneficiaries in one program are automatically enrolled in other programs for which they are eligible;
    • to the maximum extent permitted by law, support streamlining State enrollment and renewal processes and removing barriers, including by eliminating face-to-face interview requirements and requiring prepopulated electronic renewal forms, to ensure eligible individuals are automatically enrolled in and retain access to critical benefit programs;
    • develop guidance for entities regulated pursuant to the Health Insurance Portability and Accountability Act (HIPAA) on providing telehealth in compliance with HIPAA rules, to improve patient experience and convenience following the end of the COVID-19 public health emergency;
    • test methods to automate patient access to electronic prenatal, birth, and postpartum health records (including lab results, genetic tests, ultrasound images, and clinical notes) to improve patient experiences in maternity care, health outcomes, and equity.
  • The White House has posted transcripts of December 10 and December 15 briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 Medicare provider enrollment relief FAQ.  Find the updated FAQ here.  These updates are intended in part to assist both new providers and those that have temporarily expanded their facilities.

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter of information about Medicare payments.  The latest edition includes articles about the two percent Medicare sequester that Congress recently delayed, changes in Medicare Advantage monoclonal antibody claims that take effect on January 1, changes in telehealth fees for originating sites, payments for opioid treatments, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has sent a letter to state Medicaid directors to help them understand new requirements related to the Consolidated Appropriations Act of 2021, which established new requirements for state Medicaid programs, including new reporting requirements for non-disproportionate share hospitals (Medicaid DSH) supplemental payments and a change in the methodology for calculating the hospital-specific DSH limit.   Find that letter here.
  • CMS has sent a letter to state Medicaid directors urging them to encourage hospitals to consider implementation of evidence-based best practices for the management of obstetric emergencies, along with interventions to address other key contributors to maternal health disparities, to support the delivery of equitable, high-quality care for all pregnant and postpartum individuals.  The letter reminds Medicaid directors that beginning with October 1, 2021 discharges, CMS adopted a new structural quality measure for the Hospital Inpatient Quality Reporting (IQR) Program that asks hospitals to attest to whether they participate in a state-wide and/or national maternal safety quality collaborative and whether they have implemented patient safety practices or bundles to improve maternal outcomes.  Find the CMS letter here.  CMS has reinforced this message with this news release.

Department of Health and Human Services

Health Policy Update

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has published a discussion paper about 3D printing medical devices at the point of care, such as hospitals and doctors’ offices.  The purpose of the paper is to gather feedback from the public to inform future policy development.  Find the FDA announcement here and the discussion paper here.  The deadline for submitting comments is February 8.

National Institutes of Health

  • The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the NIH’s “Monitoring the Future” survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States.  In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975.   Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • Members of the Medicare Payment Advisory Commission met virtually last week.  Among the subjects MedPAC commissioners and staff discussed were hospital inpatient services, hospital outpatient services, physician services, ambulatory surgical center services, outpatient dialysis, hospice care, skilled nursing facilities, home health, inpatient rehabilitation facilities, and long-term-care hospitals.  Go here to find the meeting presentations on these subjects and go here to see a transcript of the meetings.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • Members of the Medicaid and CHIP Payment and Access Commission met virtually last week.  Among the subjects MACPAC commissioners and staff discussed were directed payments in Medicaid managed care, “money follows the person” program residency criteria, monitoring access to care for Medicaid beneficiaries, behavioral health services, health equity, and nursing facility staffing issues.  For a summary of the meeting and links to the presentations made during the two days of meetings, go here.
  • MACPAC has released the 2021 edition of the MACStats:  Medicaid and CHIP Data Book, with updated data on national and state Medicaid CHIP enrollment, spending, benefits, and beneficiaries’ health, service use, and access to care.  Find this year’s data book here.

Government Accountability Office (GAO)

  • The CARES Act, the Consolidated Appropriations Act of 2021, and the American Rescue Plan all appropriate funds to address behavioral health challenges created by the COVID-19 pandemic and the CARES Act requires the GAO to report on the challenges these funds are addressing and the effect they are having.  The GAO’s findings can be found in its new report “Behavioral Health and COVID-19:  Higher Risk Populations and Related Federal Relief Fund.  Find a summary of the report here and the full report here.

Federal Health Policy Update for Tuesday, November 23

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, November 23.  Some of the language used below is taken directly from government documents.

The White House

Provider Relief Fund

  • HHS announced that it has begun distributing $7.5 billion in American Rescue Plan rural payments to providers and suppliers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), and Medicare beneficiaries.  The average payment is $170,700, with payments ranging from $500 to $43 million for an entire health system.  More than 40,000 providers in all 50 states, Washington, D.C., and six territories will receive these rural provider payments.  Learn more from this HHS news release.  In addition, go here for a state-by-state breakdown of the payments and here for a data set with all of the recipients of this $7.5 billion in rural provider payments.
  • HHS’s Health Resources and Services Administration, which administers the Provider Relief Fund, has established a 60-day grace period for complying with the fund’s Reporting Period 1.  The grace period began on October 1, 2021, and will end on November 30, 2021 at 11:59 p.m. (eastern).  Learn more here, under “60-Day Grace Period – Reporting Period 1.”

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has posted a presentation titled “Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options.”  The presentation includes information about therapeutics and their use and distribution, guidelines for determining appropriate treatments, and links to presentations and other resources.  Find the presentation here.

Health Policy Update

  • HHS has announced that it will be awarding an additional $1.5 billion to help grow and diversify the nation’s health care workforce and bolster equitable health care in the communities that need it most.  These awards are supporting the National Health Service Corps, Nurse Corps, and Substance Use Disorder Treatment and Recovery programs, which address workforce shortages and health disparities by providing scholarship and loan repayment funding for health care students and professionals in exchange for a service commitment in hard-hit and high-risk communities.  Learn more about these new resources for health care workforce development in this White House news release and another news release from HHS.
  • HHS has announced the availability of $35 million in American Rescue Plan funding to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers.  HHS plans to use funds to award an estimated 60 one-time grants to active Title X grantees.  Applicants can begin the application process on Grants.gov and must apply by February 3.  Learn more from this HHS news release.
  • A new HHS report concludes that millions of Americans with private health insurance experience some kind of surprise medical billing.  The report found that surprise medical bills are relatively common among privately insured patients and can average more than $1,200 for services provided by anesthesiologists, $2,600 for surgical assistants, and $750 for childbirth-related care.  HHS has issued the report as it continues to develop regulations implementing the No Surprises Act, which was enacted earlier this year.  Learn more about the report from this HHS news release and see the full issue brief “Evidence on Surprise Billing: Protecting Consumers with the No Surprises Act.”
  • HHS has announced the creation of a new federal advisory committee, the Ground Ambulance and Patient Billing Advisory Committee.  As mandated by the No Surprises Act, the new advisory committee will be charged with providing recommendations to the secretaries of HHS, Labor, and Treasury on ways “to protect consumers from exorbitant charges and balance billing when using ground ambulance services.”  Learn more about the new Ground Ambulance and Patient Advisory Committee, its composition, and its scope of endeavor from this HHS news release and this Federal Register notice.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS’s Center for Medicare and Medicaid Innovation has published an evaluation of year six of its Independence at Home Demonstration, in which selected primary care practices provide home-based primary care to targeted chronically ill beneficiaries for a three-year period, with CMS tracking beneficiaries’ care experience through quality measures and paying incentives to practices that meet quality measures while generating savings for Medicare.  Go here to learn more about the program and find a link to the program’s year-six evaluation.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

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.

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.

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 Thursday, October 28

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, October 28.  Some of the language used below is taken directly from government documents.

The White House

  • The Biden administration has updated its “Build Back Better Framework” to reflect the results of recent negotiations between the White House and congressional Democrats.  Congress’s next steps on the Build Back Better Act, the social spending reconciliation bill, are unclear.  The $1.75 trillion framework is far short of the $3.5 trillion plan embraced by congressional progressives.  The text of the bill, HR 5376, was released this afternoon and is currently being debated in the House Rules Committee.  Support among progressive Democrats is uncertain.  Because this is a Democrat-only bill, Democrats can only lose three votes in the House if the bill is to pass.
  • The White House has posted a transcript of the October 27 press briefing given by its COVID-19 response team and public officials.  Go here to see the slides presented during the briefing.

Provider Relief Fund:  Phase 3 Payment Reconsideration and Phase 4 Applications

  • HHS’s Health Resources and Services Administration (HRSA) has updated its Provider Relief Fund web page with the following explanation:
  • The deadline to initiate an application for both Provider Relief Fund (PRF) Phase 4 and American Rescue Plan (ARP) Rural payments has passed.  Applicants who submitted their Tax Identification Number (TIN) for validation prior to the deadline now have until November 3, 2021 at 11:59 PM EST to submit a completed application.
  • 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 is November 12.

Department of Health and Human Services

Health Policy News

  • HHS has announced the availability of up to $256 million in grant funding to support equitable, affordable, client-centered, and high-quality family planning services through the Title X family planning program.  Title X services are delivered through a diverse network of clinics, including state and local health departments, federally qualified health centers, hospital-based sites, and other private non-profit and community-based health centers.  These grants will focus on supporting national efforts to achieve health equity by implementing and expanding access to affordable, client-centered, quality family planning services, with a priority on grants that provide services to low-income clients.  To learn more, see HHS’s news release with this announcement and go here for information about eligibility and applying for grants.  Applications for grants that will range in size from $200,000 to $22 million are due January 11, 2022.
  • HHS has released a new overdose prevention strategy designed to increase access to a full range of care and services for individuals who use substances that cause overdoses and for members of their families.  This new strategy focuses on the multiple substances involved in overdose and the diverse treatment approaches for substance use disorder.  The strategy prioritizes four key target areas – primary prevention, harm reduction, evidence-based treatment, and recovery support – and reflects principles of maximizing health equity for underserved populations, using best available data and evidence to inform policy and actions, integrating substance use disorder services into other types of health care and social services, and reducing stigma.  Learn more from this HHS news release announcing the new strategy and from the new web site HHS has established to explain and support it.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online newsletter on Medicare and Medicare payment matters.  The new edition includes information about the upcoming flu season and flu vaccines, on how CMS is correcting some skilled nursing facility claims, proper billing practices for home health care, and more.  Find these articles and more in the latest edition of MLN Connects.
  • CMS has extended the deadline for home health agencies to request reconsideration of a CMS letter of non-compliance with Home Health Quality Reporting Program requirements for an additional week, to November 17, 2021 at 11:59 pm.  Go here to learn more about that quality reporting program and reporting reconsideration and extensions.

Centers for Disease Control and Prevention

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.

Federal Health Policy Update for Tuesday, October 26

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, October 26.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

HHS’s Health Resources and Services Administration (HRSA) has made 18 changes in its Provider Relief Fund FAQ that address Provider Relief Fund Phase 4 funding.  They are:

  • p. 7 – about returning Provider Relief Fund money
  • p. 8  – for providers interested in receiving Provider Relief Fund money they previously rejected
  • pp. 10 (two questions) and 14 (also two questions) – consideration for Provider Relief Fund grants for providers that have been through a merger or acquisition
  • p. 22 – use of Provider Relief Fund and rural hospital payments
  • p. 22 – cost-based reimbursement and Provider Relief Fund money
  • p. 35 – late report submissions
  • p. 61 – treatment of prior Provider Relief Fund payments in the calculation of Phase 4 payments
  • p. 61 – mandatory inclusion of all TINs in Phase 4 applications
  • p. 66 – deadline for submission
  • p. 67 – selection of exempt payee code when applying
  • p. 68 – selection of provider type
  • p. 68 – reporting on net patient revenue
  • p. 69 – ability to revise Phase 4 data after submission
  • p. 69 – submitting more than one Phase 4 application
  • p. 69 – accounting for prescription drug sales

Provider Relief Fund:  Phase 3 Payment Reconsideration

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 is November 12.

Centers for Medicare & Medicaid Services

The FY 2022 Medicare inpatient prospective payment rule delayed addressing a proposed application process for new residency slots.  CMS has now opened a comment period on the application form for related data collection.  The Federal Register notice inviting public comment is available here and the proposed form itself can be found here.  Appendix A is the application form open for public comment.  Based on the form, it appears CMS is keeping the application in line with the original proposal, limiting the request for new slots to 1.0 FTE and requiring hospitals applicants to identify a Health Professions Shortage Area (HPSA) where that resident would spend more than 50 percent of his or her time at either the main hospital campus or a provider-based facility.  Comments on this form must be received by CMS no later than December 21, 2021.

Equal Employment Opportunity Commission

The Equal Employment Opportunity Commission has posted information about what employers should know about COVID-19 and the Americans with Disabilities Act, the Rehabilitation Act, and other equal employment opportunity laws.

Stakeholder Events

Medicaid and CHIP Payment and Access Commission meeting – October 28-29

The Medicaid and CHIP Payment and Access Commission (MACPAC) will meet on Thursday, October 28 and Friday, October 29 beginning at 10:30 a.m. both days.  Find the meetings’ agendas here and go here to register to participate in the virtual meetings.

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.

 

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.