Federal Health Policy Update for Wednesday, January 19

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

Public Health Emergency Declaration Renewed

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

Free COVID-19 Tests and Masks

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

White House

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

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

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

Centers for Disease Control and Prevention

COVID-19

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

Health Policy Update

Food and Drug Administration

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

FEMA

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

Congressional Research Service

U.S. Preventive Services Task Force

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

Stakeholder Events

MACPAC – January 20-21

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

Federal Health Policy Update for Thursday, January 13

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

Supreme Court

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

White House

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

Learn more from this White House fact sheet.

Medicare Payment Advisory Commission

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

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

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

MedPAC – January 14

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

CMS – January 18

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

MACPAC – January 20-21

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

 

Federal Health Policy Update for Tuesday, January 11

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

Provider Relief Fund

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

Department of Health and Human Services

COVID-19

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

Health Policy Update

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

Centers for Medicare & Medicaid Services

Health Policy Update

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

COVID-19

Centers for Disease Control and Prevention

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

Food and Drug Administration

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

Medicare Payment Advisory Commission (MedPAC)

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

Congressional Research Service

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

Stakeholder Events

CDC – Clinical Outreach Communication Activity – January 12

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

MedPAC – January 13-14

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

MACPAC – January 20-21

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

Federal Health Policy Update for Thursday, January 6

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

Provider Relief Fund

The White House

Department of Health and Human Services

COVID-19 Hospital Data Reporting Requirements

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

COVID-19

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

Health Policy Update

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

Centers for Medicare & Medicaid Services

Health Policy Update

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

Centers for Disease Control and Prevention

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

Food and Drug Administration

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Stakeholder Events

MedPAC – January 13-14

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

MACPAC – January 20-21

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

 

Federal Health Policy Update for Monday, January 3

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

The White House

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

Provider Relief Fund

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

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

Occupational Safety and Health Administration (OSHA)

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Stakeholder Events

HHS Office of the Assistant Secretary for Preparedness – January 6

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

MedPAC – January 13-14

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

MACPAC – January 20-21

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

Federal Health Policy Update for Monday, December 27

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

Surprise Medical Billing Law Implementation Update

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

The White House

Provider Relief Fund

Centers for Medicare & Medicaid Services

Health Policy Update

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

COVID-19

Department of Health and Human Services

COVID-19

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

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

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

The statement also explains that

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

Find the complete statement here.

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

MACPAC (Medicaid and CHIP Payment and Access Commission)

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

MedPAC Meets

The government agency that advises Congress on Medicare payment matters met publicly in Washington, D.C. last week.

During the virtual meeting, members of the Medicare Payment Advisory Commission discussed and debated future Medicare payments for:

  • hospital inpatient services
  • hospital outpatient services
  • physician services
  • ambulatory surgical center services
  • outpatient dialysis
  • hospice care
  • skilled nursing facilities
  • home health
  • inpatient rehabilitation facilities
  • long-term-care hospitals

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of community safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

For a look at the agenda for the two-day meeting and to find the presentations for each of these subjects, go here.

NASH Asks Congress to Block Medicare Sequestration Cuts

Stop the looming Medicare sequestration cuts, NASH asked in a message it sent to members of Congress on Tuesday, December 7.

The cuts – a resumption of the long-time two percent Medicare sequestration and an additional four percent sequestration cut necessitated by federal PAYGO rules – would pose a problem for community safety-net hospitals that still find themselves caring for significant numbers of COVID-19 patients amid rising costs, supply chain challenges, and rising personnel costs and labor shortages.

Go here to see NASH’s message to Congress.

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 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.