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 Thursday, December 9

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, December 9.  Some of the language used below is taken directly from government documents.

Update on Efforts to Delay Medicare Sequestration Cuts

The Senate has advanced S 610, a bill that would:

  • Extend the COVID-19-driven moratorium on the long-time two percent Medicare sequestration until the end of March 2022, reducing that sequestration from two percent to one percent from the beginning of April through the end of June 2022.
  • Avoid the additional four percent sequestration necessitated by federal PAYGO rules by moving the additional spending PAYGO cuts need to offset onto the federal balance sheet for FY 2023.
  • Include a procedural provision that would enable the Senate to pass legislation to lift the debt ceiling with only 50 votes (addressing the debt ceiling will require separate legislation).
  • Reduce the 3.75 percent cut in Medicare evaluation and management rates, which Congress halted last year but that was scheduled to resume on January 1, to a 0.75 percent cut.
  • Delay certain Medicare laboratory payment cuts.
  • Delay the launch of the Radiation Oncology Model until 2023.

Final passage of this bill is expected by the end of this week.

The White House

Centers for Medicare & Medicaid Services

Health Policy Update

Department of Health and Human Services

Health Policy Update

  • HHS and the White House have issued a “call to action” to improve maternal health and equity and address what they characterize as a maternal mortality and morbidity crisis. Learn more about this initiative from the following resources:
    • A White House fact sheet that describes the various components of this program.
    • A White House news release that lists more than two dozen private sector organizations that will be initial participants in this effort and that describes the specific roles they will play.
    • An HHS news release about the initiative.
    • Remarks from Vice President Kamala Harris about the program.
    • Remarks from HHS Secretary Xavier Becerra about the undertaking.
    • A CMS news release announcing that the agency will establish a “Birthing-Friendly” designation to drive improvements in perinatal health outcomes and maternal health equity. The designation, which would be indicated on the Hospital Compare web site, would initially identify hospitals that provide perinatal care, are participating in a maternity care quality improvement collaborative, and have implemented recommended patient safety practices.
    • An issue brief from HHS’s Office of the Assistant Secretary for Planning and Evaluation titled “Medicaid After Pregnancy: State-Level Implications of Extending Postpartum Coverage.”
    • An announcement that HHS’s Office on Women’s Health has revealed the 20 winners of Phase I of HHS’s Hypertension Innovator Award Competition.  The competition was created to identify effective, existing programs that care for people with hypertension where the programs could be or are already applied to women with hypertension who are pregnant and/or postpartum. Go here for the announcement and a list of the winners and brief descriptions of their programs.
    • A news release from the NIH announcing that the agency will offer up to $1 million in cash prizes for innovative diagnostic technologies to help improve maternal health around the world in conjunction with the White House “day of action” on maternal health. Submissions will be accepted from January 5, 2022 through April 22.  For more information about the program and details about eligibility, rules, and how to register and participate, go here.
  • HHS and the administration have introduced a series of substance abuse prevention and treatment initiatives under the broad rubric of “harm reduction.” Resources with further information about this effort include:
    • HHS Secretary Xavier Becerra’s remarks during a press call announcing the administration’s harm reduction efforts.
    • HHS’s The Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it is accepting applications for the first-ever SAMHSA Harm Reduction grant program and expects to issue $30 million in grant awards: $10 million a year over the next three years to support harm reduction services.  This funding will seek to increase access to a range of community harm reduction services and support harm reduction service providers as they work to help prevent overdose deaths and reduce health risks often associated with drug use.  Learn more about the program, its objectives, and the kinds of services it will fund in this HHS news release and go here for additional information about the program, eligibility, and how to apply for funding.  Applications for the first round of funding are due February 7, 2022.
  • HHS and its Health Resources and Services Administration have awarded approximately $82 million in emergency home visiting funds to 56 entities – states, jurisdictions, and non-profit organizations – to support children and families affected by the COVID-19 pandemic. This Maternal, Infant, and Early Childhood Home Visiting Program supports the delivery of high-quality, voluntary, evidence-based home visiting services to children and families living in communities at risk for poor maternal and child health outcomes.  Learn more from this HHS news release and go here to see a list of the grant recipients from this and a previous round of $40 million in funding.
  • Surgeon General Dr. Vivek Murthy has issued an advisory to highlight “the urgent need to address the nation’s youth mental health crisis,” citing in particular the impact of the COVID-19 pandemic on the mental health of the country’s young people and families. The advisory outlines a series of recommendations to improve youth mental health.  Go here to see the HHS news release about the advisory and go here to see the advisory itself.
  • HHS and the Department of Housing and Urban Development have announced the expansion of a program established earlier this year to improve access to affordable, accessible housing and services that make community living possible. A new Housing and Services Resource Center will serve as the hub for this effort, implementing a federally coordinated approach to providing resources, program guidance, training, and technical assistance to public housing authorities and housing providers; state Medicaid, disability, aging and behavioral health agencies; the aging and disability networks; homeless services organizations and networks; health care systems and providers; and tribal organizations.  Learn more about the program from this HHS news release and from the new Housing and Services Resource Center web site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization for the Pfizer COVID-19 vaccine to authorize the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer vaccine. See this FDA announcement and an explanation of the agency’s decision.
  • The FDA has issued emergency use authorization for the monoclonal antibody Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prevention of COVID-19 in certain adults and pediatric individuals. The product is only authorized for those individuals who are not currently infected with the COVID-19 virus and who have not recently been exposed to an individual infected with the virus.  Learn more from this FDA announcement and this manufacturer’s fact sheet.
  • The FDA has updated its SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, including FDA recommendations for clinical laboratory staff and health care providers.  The update also adds new information about COVID-19 tests whose performance could be affected by COVID-19 genetic mutations, such as those found in the omicron variant, in patient samples.

National Institutes of Health

  • HHS Secretary Xavier Becerra announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the NIH, will serve as the acting director of the NIH effective December 20, 2021.  Go here to see the announcement and learn about Dr. Tabak.

Stakeholder Events

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 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 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 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 Thursday, November 4

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, November 4.  Some of the language used below is taken directly from government documents.

New Federal Vaccination Requirements

CMS has unveiled its new COVID-19 vaccine requirements for health care providers that receive reimbursement from the federal government.  The highlights include:

  • CMS is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs.
  • The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types:  ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, hospitals, intermediate-care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies, public health agencies as providers of outpatient physical therapy and speech-language pathology services, psychiatric residential treatment facilities, Programs for All-Inclusive Care for the Elderly Organizations (PACE), rural health clinics/federally qualified health centers, and long-term care facilities.
  • Facilities covered by this regulation must establish a policy ensuring that all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.  All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022.  The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices.
  • The regulation addresses who, among health care facilities’ employees, are subject to this requirement.  These requirements, it notes, must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients:  facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.
  • These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff.
  • Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities.  CMS has concluded that it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those who physically enter facilities, clinics, homes, or other sites of care.
  • Transplant centers, psychiatric hospitals, and swing beds are governed by the infection control conditions of participation for hospitals and are thus subject to the staff vaccination requirements issued in this rule.
  • Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this rule.  Providers should identify and monitor these individuals as a part of implementing the policies and procedures of this rule.
  • The rule encompasses administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services staff, and others.  Regulators considered excluding individual staff members who are present at the site of care less frequently than once a week from these vaccination requirements but were concerned that this might lead to confusion or fragmented care, so any individual who performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated.
  • Regulators noted that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals.  Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), delivery, or repair personnel.
  • When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this rule, facilities are told to consider frequency of presence, services provided, and proximity to patients and staff.  For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements because they are using the same common areas used by staff, patients, and visitors.
  • To learn more, please consult the following resources:
  • OSHA has announced a new emergency temporary standard to protect more than 84 million workers from the spread of COVID-19 on the job.  Under this standard, covered employers (those with 100 or more employees) must develop, implement, and enforce a mandatory COVID-19 vaccination policy unless they adopt a policy requiring employees to choose either to be vaccinated or to undergo regular COVID-19 testing and wear a face covering at work.  Learn more from this OSHA news release and the agency’s formal Emergency Testing Standard, as published in the Federal Register.

New Medicare Regulations

CMS has released a number of final Medicare regulations.  The following are those final rules and links to additional information about them.

  • Hospital outpatient prospective payment system, ambulatory surgical center prospective payment system, price transparency, and radiation oncology model rule – changes include a two percent rate increase; restoration of the inpatient-only procedure list and most procedures that were removed from that list last year; continuation of 340B payments at average sale price minus 22.5 percent; changes in the hospital price transparency rule that leave hospitals with more than 30 beds subject to fines of up to $5500 a day or more than $2 million a year; changes in the quality reporting program, including a measure for COVID-19 vaccination rate among health care workers; and some changes in the Radiation Oncology Model program that begins on January 1, 2022, including invoking its “Extreme and Uncontrollable Circumstances Policy” for the program.  To learn more, see the following resources:
  • For more on the “Extreme and Uncontrollable Circumstances Policy” and its application to the Radiation Oncology Model, go here and scroll down.
  • Physician fee schedule – changes include an overall reduction of nearly nine percent in physician payments; a reduction of the conversion factor from the current $34.89 to $33.59; and provisions for the expanded use of telehealth.  To learn more, see the following resources:
  • Home health prospective payment system – changes include a 3.2 percent rate increase, changes in the Medicare conditions of participation, and provisions for expanded use of telehealth.  To learn more, see the following resources:
  • CMS has issued a final rule that updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2022.  This rule also finalizes updates to the Acute Kidney Injury program dialysis payment rate for renal dialysis services furnished by ESRD facilities.  It also finalizes modifications to the ESRD Treatment Choices Model policies to encourage certain health care providers to reduce disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status.  To learn more, see the following resources:

The White House

Congress

  • Yesterday, House Democrats released the text of its reconciliation bill, H.R. 5376 – the Build Back Better Act.  This bill includes a provision that provides a glide-path to ending the enhanced 6.2% Medicaid federal matching percentage established by the Families First Coronavirus Response Act passed in March last year.  The enhanced FMAP would be phased out as follows:
    • April 1, 2022, the enhanced FMAP lowered  to 3.0 percentage points;
    • July 1, 2022, enhanced FMAP lowered to 1.5 percentage points;
    • October 1, 2022, enhanced FMAP expires.
  • House Speaker Nancy Pelosi hopes the House will vote on the domestic spending reconciliation bill as early as this evening, to be followed by a vote on the bipartisan, Senate-passed infrastructure bill on Friday.  House Democrats have continued to negotiate changes in the reconciliation bill to gain more support, though it is unclear whether those changes have persuaded enough Democrats in the House to support the bill at this time.  Also unclear is whether the House bill will comply with the Senate’s procedural rules or whether this bill will have the support of all 50 Democratic senators.

Provider Relief Fund:  Phase 3 Payment Reconsideration

  • The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated.  Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology.  Go here for further information.  The deadline for submitting requests for reconsideration of Phase 3 payments is November 12.

Department of Health and Human Services

Health Policy News

  • HHS has proposed eliminating the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) regulation, adopted in January of this year, that would have eliminated department regulations after ten years unless HHS took specific action to renew them.  In proposing to reverse the rule, HHS cited its previous failure to consider stakeholder objections to the rule, the burden it would place on the agency, and its potentially negative effect on medically vulnerable populations.  See HHS’s proposed rule overturning the SUNSET regulation in this Federal Register notice.
  • HHS has awarded $3.37 billion in relief funds through the Low Income Home Energy Assistance Program (LIHEAP) to help low-income individuals and families afford home heating costs this winter and cover unpaid utility bills.  This supplements $4.5 billion in LIHEAP funds from the American Rescue Plan Act that were released in May.  Learn more about this new LIHEAP funding and how interested parties can apply for assistance in this HHS news release.
  • HRSA has issued an interim update to its strategic plan to ensure alignment with the administration’s and HHS’s priorities, such as their emphasis on health equity, and the expansion of HRSA’s program responsibilities.  Go here to learn about the updated interim plan.
  • HRSA has opened its application process for three of its loan repayment programs with the support of an additional $800 million made available through the American Rescue Plan.  Eligible clinicians providing primary medical, dental, behavioral health care services, or evidence-based substance use disorder treatment can qualify for loan repayment of up to:
  • $50,000 for the NHSC Loan Repayment Program
  • $75,000 for the NHSC Substance Use Disorder Workforce Loan Repayment Program
  • 100,000 for the NHSC Rural Community Loan Repayment Program

Go here to learn more about eligible clinicians.  Applications are due December 16.

  • HHS’s Indian Health Service has announced $46.4 million in funding opportunities to address suicide, domestic violence, and substance abuse and for support for an integrative approach to the delivery of behavioral health services for American Indians and Alaska Natives.  Go here to learn more about the funding opportunities.  Applications are due February 2.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has reminded eligible consumers and providers that coverage for COVID-19 vaccines for children from the ages of five to 11 is available without cost-sharing under Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and in the commercial market.  Under the terms of the CDC’s COVID-19 Vaccination Program Provider Agreement, health care providers and other entities administering COVID-19 vaccines must agree not to deny anyone a COVID-19 vaccination based on their health coverage status and also must agree to administer COVID-19 vaccines at no out-of-pocket cost to recipients.  Learn more from this CMS news release.
  • CMS has posted a quick start guide to CLIA certification for COVID-19 testing in the workplace and an accompanying FAQ.

Health Policy News

  • CMS has extended two deadlines affecting hospitals that participate in its Hospital Inpatient Quality Reporting Program and/or the Medicare Promoting Interoperability Program.  As described in this CMS notice,
  • The deadline for the submission of electronic clinical quality measure (eCQM) data for the calendar year 2021 reporting period, pertaining to the FY 2023 payment determination, has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • The Medicare Promoting Interoperability Program attestation deadline for eligible hospitals and critical access hospitals has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • CMS has posted the latest edition of MLN Connects, its online newsletter.  Included in the new release are articles about changes for Medicare Advantage plan claims for COVID-19 vaccines and monoclonal antibodies that will take effect on January 1, 2022; changes in Medicare billing practices; a new web-based training program on post-acute care quality reporting programs; and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released an updated fact sheet, based on recent legislative changes, to help states and advocacy organizations understand what health coverage options are available to Afghan evacuees.  Find that fact sheet here.

Food and Drug Administration

Centers for Disease Control and Prevention

National Institutes of Health

  • The NIH’s Rapid Acceleration of Diagnostics initiative has announced the launch of the “When To Test Calculator for Individuals,” a companion to the version for organizations introduced last winter.  By responding to just a few prompts, the new online individual impact calculator indicates whether a person should get a test and when.  The calculator includes answers to frequently asked questions and links to resources on testing strategies and on obtaining supplies, including home tests.  Learn more from this NIH announcement.
  • The NIH will support a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with the virus during pregnancy.  The study also will follow their offspring for any potential long-term effects.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has updated “Payment Basics,” its series of brief overviews of how Medicare’s payment systems function.  The agency produces Payment Basics as a resource for policy-makers and others to better understand how Medicare pays for health care services.  Much of the update reflects COVID-19-related payment changes.  Find the series here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC met on Thursday, October 28 and Friday, October 29.  For a summary of the meeting and links to the agenda and presentations made during the meeting, go here.
  • MACPAC has published a new issue brief that describes the use and oversight of upper-payment limit (UPL) payments for hospitals, nursing facilities, and physicians based on its review of provider-level data submitted by states to CMS to demonstrate compliance with UPL requirements.  The brief concludes with a discussion of current policy issues, including the new requirement for CMS to make provider-level UPL data publicly available.  Find the brief here.

Government Accountability Office (GAO)

  • The GAO recently evaluated the effectiveness of the federal government’s organization of the distribution of COVID-19 vaccines and its communication about those efforts and has published its findings and recommendations in the new report “COVID-19:  HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives.”  Find a summary of the report here and the full report here.

Congressional Research Service

Stakeholder Events

Medicare Payment Advisory Commission (MedPAC) – November 8 and 9

MedPAC will hold virtual meetings on November 8 and 9.  For information about times, agenda, and how to join the meeting go here.

CMS – Medicare Clinical Laboratory Fee Data Collection and Reporting Webinar – November 10

CMS will hold a webinar on Medicare clinical laboratory private payer data collection and reporting on Wednesday, November 10 at 3:30 p.m. (eastern).  Go here to register to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

CMS – COVID-19 Vaccines and Rural Communities – November 15

CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas.  Go here for further information about the webinar and to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

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.

Federal Health Policy Update for Tuesday, October 12

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, October 12.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Reminder That Applications Are Now Being Accepted

  • The Health Resources and Services Administration (HRSA) has opened its portal for providers to apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application period runs for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has launched a Spanish version of its QuestionBuilder app, which can help Latino patients prepare for their in-person or telehealth appointments.  Go here to learn more about the app and its features.
  • HHS’s Office of the National Coordinator for Health Information Technology has launched a new initiative called USCDI+ to support the identification and establishment of domain- or program-specific datasets that will operate as extensions of the existing USCDI.  In particular, USCDI+ is a service that ONC will provide to federal partners that seek to establish, harmonize, and advance the use of interoperable datasets that extend beyond the core data in the USCDI to meet agency-specific programmatic requirements.  Learn more from ONC’s USCDI+ web page.
  • HHS has released its Climate Adaptation and Resilience Plan to bolster the resilience of its operations and assets from the accelerating impacts of climate change.  The plan provides a road map for assuring that all parts of the department address the threats to health and well-being related to climate change for all people in the United States, especially those most vulnerable. The plan also ensures continuity of operations of HHS facilities in the face of extreme weather events and fosters healthy greenhouse gas reduction and resilience efforts in the public health sector and community.  Learn more about the plan from this HHS news release, the plan itself, and an HHS policy statement about the plan.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 frequently asked questions on Medicare fee-for-service billing with new information about the application of the revised definition of “direct supervision” to the work of physical therapists and occupational therapists.  Find the new information here, on page 172.
  • CMS has updated its COVID-19 emergency declarations blank waivers for health care providers to waive certain requirements for Medicare-dependent hospitals for the rest of the official public health emergency period.  See the new information on page 12 of the blanket waivers document.

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online newsletter covering Medicare policy.  The new edition includes articles about a modification of the Medicare-dependent hospital waiver, a quarterly update of the end-stage renal disease prospective payment system, FY 2022 updates of the inpatient psychiatric facilities prospective payment system, new claims-based measures added to the hospice quality reporting program, and more.  Find the new edition of MLN Connects here.
  • CMS has released its 2022 star ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans to help people with Medicare compare plans ahead of Medicare open enrollment, which begins on October 15.  Learn more about the star ratings and find additional resources in this CMS news release.
  • CMS has issued a new report describing what Z codes for social determinants of health revealed about Medicare fee-for-services beneficiaries in 2019.  Find the report here.

Centers for Disease Control and Prevention

National Institutes of Health

  • More than 140,000 children in the U.S. have lost a primary or secondary caregiver because of COVID-19, the NIH reports.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC met last week.  Issues on its agenda included addressing the high prices of pharmaceutical products and other technologies covered by Medicare; data on Medicare’s net prices for prescription drugs and other drug pricing metrics; a report for Congress on vulnerable Medicare beneficiaries’ access to care; features of Medicare’s alternative payment models; improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions; and the Medicare hospital wage index.  Go here to find the briefs and presentations used to guide the commissioners’ discussions; a transcript should appear at this site as well later this week.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 13 and 21

The Health Resources and Services Administration will hold web events on Wednesday, October 13 and Thursday, October 21 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking such grants.

  • To register for the October 13 webcast, go here.
  • To register for the October 21 webcast, go here.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13 and October 14

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 and October 14.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

Federal Health Policy Update for Tuesday, September 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, September 28.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Application Reminder

  • Beginning on September 29, health care providers may apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application period will run for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

Provider Relief Fund:  More Information

  • HHS has updated its information on Phase 4 Provider Relief Fund grants and American Rescue Plan grants for rural providers.  The new information includes:
    • Types of eligible providers.
    • An explanation that although general distribution payments will be allocated based on “changes to operating revenue and expenses” from July 1, 2020 to March 31, 2021, the payments can be used to cover eligible lost revenue and expenses incurred from January 1, 2020 through December 31, 2022.
    • The addition of the time period for identifying care provided to individuals living in rural areas:  January 1, 2019 through September 30, 2020.
  • The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking grants.  Learn more here and find a link to register to participate.  HRSA has announced that it will hold additional sessions during the weeks of October 11 and October 18; dates and times for those events have not yet been announced.
  • HHS recently hosted a briefing session to provide information about these upcoming funding opportunities.  View a video of that session here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has awarded nearly $1 billion in American Rescue Plan funding to nearly 1300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects.  According to HHS, health centers will use this funding for COVID-19-related capital needs, constructing new facilities, renovating and expanding existing facilities to enhance response to pandemics, and purchasing new state-of-the-art equipment, including telehealth technology, mobile medical vans, and freezers to store vaccines.  Learn more about the funding, its intended use, and how much money was granted to facilities in each state in this HHS news release.
  • Following up on a previously announced commitment, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has announced the distribution of $825 million in federal funds to 231 community mental health centers across the country.  This grant program is intended to enable community mental health centers to more effectively address the needs of individuals who have a serious emotional disturbance or mental illness, often accompanied by substance use disorders.  For a more detailed description of the work the community mental health centers are expected to do with this money and a link to a list of the 231 facilities awarded grants, see this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • Following the FDA’s recent authorization of a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the CDC, CMS will continue to provide coverage for booster doses without cost-sharing.  Beneficiaries with Medicare will pay nothing for COVID-19 vaccines or their administration and there is no copayment, coinsurance, or deductible.  In addition, nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration without cost-sharing.  COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market.  Learn more from this CMS news release.

Health Policy News

  • CMS has posted a special edition of its online newsletter MLN Connects explaining that effective September 20 it is exercising enforcement discretion for skilled nursing facility consolidated billing provisions related to flu and pneumococcal vaccines that enables Medicare-enrolled immunizers, including pharmacies, to bill directly and get direct reimbursement from Medicare, including for vaccine administration and product, whether these vaccines are administered at the same time (co-administered) as a COVID-19 vaccine or at different times.  Find the notice here.

Centers for Disease Control and Prevention

National Institutes of Health

  • The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.  The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses such as COVID-19.  Learn more about the anticipated research and the grant recipients in this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC commissioners met last week to discuss a variety of Medicaid and CHIP payment and access issues, including communicating with beneficiaries, workforce issues, monitoring access to care, health IT adoption among behavioral health providers, and vaccines for adults.  Go here for a summary of the meeting and links to issue briefs prepared to support the commissioners’ discussions.

Government Accountability Office (GAO)

  • The GAO has published a short report that draws from a number of past GAO reports to describe examples of racial and ethnic health disparities, barriers that may contribute to disparities, and federal efforts to help address them.  In this report the GAO cites policy considerations and reiterates recommendations to improve gaps in race and ethnicity data.  Learn more in “GAO Health Care Capsule:  Racial and Ethnic Health Disparities.”
  • In 2016, HHS selected eight states to participate in a time-limited demonstration to establish certified community behavioral health clinics to help improve their response to depression and opioid use challenges within their Medicaid populations.  The GAO has now reviewed the efforts of those states, including the degree to which spending on these services changed during the demonstration period, and has offered recommendations on provider payments and overlap with other Medicaid payments.  Learn more from the GAO report “Medicaid Behavioral Health:  CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication.”

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30.  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

HHS/Office of the Assistant Secretary for Preparedness and Response – Grand Rounds for EMS, Critical Care, and Emergency Department ICU Care of Pediatric COVID Patients – September 30

The agency’s “clinical rounds” sessions return on Thursday, September 30 at noon (eastern) with presenters who will discuss emergency management resources and information that can be used to improve operations during the COVID-19 pandemic.  Go here to register to participate in the remote event.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13 and October 14

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 and October 14.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.