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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 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 Wednesday, November 10

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

The White House

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

Provider Relief Fund:  Phase 3 Payment Reconsideration

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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

HHS/Center for Medicare and Medicaid Innovation

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

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

Questions from CMMI

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

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

Centers for Medicare & Medicaid Services

COVID-19

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

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

Stakeholder Events

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

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

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

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

CDC – Antibiotic Prescribing and COVID-19 – November 18

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

Federal Health Policy Update for Tuesday, October 26

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

Provider Relief Fund

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

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

Provider Relief Fund:  Phase 3 Payment Reconsideration

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

Centers for Medicare & Medicaid Services

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

Equal Employment Opportunity Commission

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

Stakeholder Events

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

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

CDC – Pediatric COVID-19 Vaccines – November 4

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

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

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

 

Federal Health Policy Update for Tuesday, September 21

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, September 21.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to CMS on the agency’s proposed outpatient prospective payment system regulation for calendar year 2022.  Writing from the perspective of private community safety-net hospitals, NASH addresses proposals and request for information about health equity, the section 340B prescription drug discount program, hospital price transparency requirements, proposed changes in Medicare’s inpatient-only procedures list, and the extension of provider flexibilities introduced in response to the COVID-19 public health emergency.  See NASH’s comment letter here.
  • In July the newly formed Congressional Social Determinants of Health Caucus invited stakeholders to respond to a series of questions designed to help the caucus learn more about social determinants of health and what Congress might do to address them more effectively.  Go here to read NASH’s response to the caucus’s questionnaire.

Provider Relief Fund

  • HHS has updated its Provider Relief Fund reporting portal’s frequently asked questions.  Find the updated FAQ here.
  • HHS has published a Provider Relief Fund reporting portal user guide.  Find the guide here.

The White House

Department of Health and Human Services

COVID-19

  • The federal government has responded to recent increases in COVID-19 cases by assuming control of the distribution of monoclonal antibodies used to treat the virus.  Learn more from the announcement of this new approach.  Federal officials also explain the new policy, why they are pursuing it, and how it will work in this video of a web event.

Health Policy News

  • HHS has extended the open enrollment period for people seeking health insurance on the federally facilitated marketplace and has extended the scope of services provided by navigators for that marketplace.  The department also has authorized state marketplaces to set their own open enrollment dates.  Learn more from this HHS news release.
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $48 million to 271 HRSA-supported health centers in 26 states, Puerto Rico, and the District of Columbia to expand HIV prevention and treatment, outreach, and care coordination services.  To learn more about the awards, how the money will be used, and the award recipients, see this HHS announcement.
  • HHS and HRSA have awarded $350 million in grants to every state to support safe pregnancies and healthy babies.  Funding will be used expand home visiting services to families most in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality.  The money is being awarded through the Maternal, Infant, Early Childhood Home Visiting Program, the Healthy Start Initiative, and the State Systems Developmental Initiative.  To learn more about how HHS intends for the money to be spent, how much money is being allocated through these programs, and how much money individual recipients will receive, see this HHS announcement.
  • HRSA has announced the availability of funding to support continued access to comprehensive, culturally competent, high-quality primary health care services for communities and populations currently served by its Health Center Program.  Eligible organizations include domestic public or non-profit private entities that propose to serve an announced service area and its associated population(s) to ensure continued access to affordable, quality primary health care services.  Learn more from this HRSA announcement.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • The latest edition of the CMS online publication MLN Connects includes Medicare’s quarterly provider quality compliance newsletter and information about annual HPSA updates, flu vaccine payment allowances, updated clinical lab fees, and more.  Find the September 16 edition of MLN Connects here.
  • CMS has posted a pre-publication version of a final rule that sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges and State-based Exchanges on the federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers’ applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.  Find the document here.
  • CMS has published three FAQs that explain that the agency will not take enforcement action against certain payers for the payer-to-payer data exchange provision of the May 2020 Interoperability and Patient Access final rule until future rulemaking is finalized.  CMS’s decision to exercise enforcement discretion for the payer-to-payer policy until future rulemaking occurs does not affect any other existing regulatory requirements and implementation timelines outlined in the final rule.  Go here to see the announcement and find links to the FAQs.
  • CMS has proposed repealing the Medicare Coverage of Innovative Technology and Definition of ‘”Reasonable and Necessary” final rule, which was published on January 14, 2021 and is scheduled to take effect on December 15.  The repealed rule was a response to concerns that breakthrough technologies were not being made available to the Medicare population in a timely manner but CMS now believes more care must be taken before authorizing the use of such technologies for Medicare patients.  Find the proposed rule here.
  • CMS has published its Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Quarterly Q&As December 2020 document so inpatient rehabilitation facility (IRF) providers have the benefit of clarifications to existing guidance.
  • CMS has published the Long-Term-Care Hospital (LTCH) CARE Data Set Quarterly Q&As, September 2021, Consolidated September 2020 to September 2021 document so LTCH providers have the benefit of the clarifications to existing guidance.
  • CMS has awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries.  Learn more about the services the grants will underwrite and find a list of grant recipients in this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its emergency use authorization (EUA) for the monoclonal antibodies bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.  In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the COVID-10 virus.  Learn more from the FDA announcement, the revised EUA, and this fact sheet for providers.
  • The FDA has updated its enforcement policy for masks, barrier face coverings, face shields, surgical masks, and respirators during the COVID-19 public health emergency.  Find the updated policy here.

National Institutes of Health

  • The NIH has awarded $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19.  Learn more from this NIH news release.

Stakeholder Events

MACPAC – September meetings – September 23 and 24

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its scheduled September meeting of commissioners on Thursday, September 23 and Friday, 24 to discuss federal Medicaid and CHIP policies.  The meetings will be held virtually.  Find the meeting agenda here and go here to register to view the sessions.

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 at 2:00 p.m. (eastern).  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.

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

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 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.