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Federal Health Policy Update for Wednesday, January 19

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

Public Health Emergency Declaration Renewed

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

Free COVID-19 Tests and Masks

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

White House

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

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

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

Centers for Disease Control and Prevention

COVID-19

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

Health Policy Update

Food and Drug Administration

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

FEMA

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

Congressional Research Service

U.S. Preventive Services Task Force

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

Stakeholder Events

MACPAC – January 20-21

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

Federal Health Policy Update for Thursday, January 13

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

Supreme Court

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

White House

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

Learn more from this White House fact sheet.

Medicare Payment Advisory Commission

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

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

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

MedPAC – January 14

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

CMS – January 18

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

MACPAC – January 20-21

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

 

Federal Health Policy Update for 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, 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 Wednesday, December 1

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

Omicron Variant

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

Health Care Employee Vaccine Mandate

COVID-19

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

No Surprises Act

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

The White House

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Stakeholder Events

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

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

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

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

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

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

MEDPAC – commission meeting – December 9-10

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

Federal Health Policy Update for Friday, November 19

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

Congress

On Friday the House passed a $1.7 trillion social spending bill, H.R. 5376 – Build Back Better Act, with no Republican votes and all but one Democratic vote.  The Congressional Budget Office score indicates that the health care policies in the bill are paid for by cuts in other health care programs.

The bill includes nearly $300 billion in health care provisions, including:

  • $57 billion to provide insurance to more than two million people in non-expansion states
  • $74 billion to temporarily extend subsidies for Affordable Care Act health plans
  • $146 billion for home health services
  • $36 billion to cover hearing services in Medicare
  • $26 billion to expand the public health workforce, address maternal mortality, and prepare for future pandemics

This new spending would be paid for in part by:

  • nearly $34 billion in savings from cuts in uncompensated care payments to hospitals in 12 states that have not expanded their Medicaid programs
  • nearly $300 billion in savings through policies to negotiate the cost of some expensive drugs, penalize drug companies that raise prices faster than inflation, redesign seniors’ Medicare benefits, and repeal the drug rebate rule

The bill that passed the House this morning is the result of a number of last-minute changes to smaller provisions from previous versions.  We are still going through that language and will update you on any changes you should be aware of.  The bill will certainly be changed by the Senate, where it will require the votes of all 50 Democratic senators to pass.

The White House

Provider Relief Fund

  • 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.”

Centers for Medicare & Medicaid Services

COVID-19

  • Effective April 1, 2022, CMS will introduce seven new ICD-10 codes for COVID-19 treatment and vaccines and the CDC will implement three new codes for reporting COVID-19 vaccination status.  To find these codes, go here and scroll down to the downloadable zip file “ICD-10 MS-DRGs V39.1 Effective April 1, 2022  (ZIP) – – Updated 11/16/2021.”
  • CMS has posted the first in a series of short podcasts for frontline nursing home staff.  “Nursing Home Series for Front Line Clinicians and Staff” addresses training and infection control practices in nursing homes to help combat the spread of COVID-19.  Find the podcast here.

Health Policy Update

  • CMS has published the latest edition of MLN Connects, its online newsletter of information about Medicare payment and other policies.  Articles in this edition address changes in nursing home visitation policies, opportunities for clinicians to review their 2020 quality payment program performance data before it is published on the Medicare Care Compare web site, the 2022 update of Medicare thresholds per beneficiary, and more.  Go here for the latest edition of MLN Connects.

Department of Health and Human Services

  • A new federal regulation requires health insurance issuers, employer-based health plans, and other group health plans to report on prescription drug and health coverage costs.  The requirement, issued as a final rule with comment period, was issued jointly by the departments of Health and Human Services, Labor, and Treasury and the federal Office of Personnel Management and was issued to implement the No Surprises Act and the transparency requirements of the Consolidated Appropriations Act of 2021.  The regulation requires health plans, health insurance issuers offering group or individual health insurance coverage, and health benefits plans offered to federal employees to submit selected data to the departments involved, which will work through the office of HHS’s Assistant Secretary for Planning and Evaluation to publish a report on prescription drug pricing trends and rebates and their impact on premiums and consumers’ out-of-pocket costs.  The data submission requirements include information on average monthly premiums and drug spending for patients compared to their employers and/or group health plans/health insurance issuers.  Learn more about the regulation from the following resources:
  • an HHS news release
  • an HHS fact sheet
  • the regulation itself
  • HHS Secretary Xavier Becerra spoke this week at the National Association of Medicaid Directors’ fall conference.  Read his remarks here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has authorized use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.  Learn more about this development, and the reasoning behind it, in this FDA news release.
  • The FDA has updated its enforcement policy for viral transport media during the COVID-19 public health emergency.  Among the audiences for this guidance is clinical laboratories.  Find the updated guidance here.

National Institutes of Health

Occupational Safety and Health Administration (OSHA)

  • In the wake of a federal court ruling that OSHA “take no steps to implement or enforce” its emergency temporary standard requiring employees of companies with 100 or more employees to be vaccinated, OSHA has suspended activities related to the implementation and enforcement of that requirement.  Learn more from this OSHA news release.

Government Accountability Office (GAO)

  • The GAO has published a report with information on the transition to alternative payment models by providers in rural areas, health professional shortage areas (HPSAs), and medically underserved areas (MUAs).  Find a summary of the report here and the full report here.

Stakeholder Events

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

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

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.