Federal Health Policy Update for Monday, January 24

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

Provider Relief Fund

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

White House

Centers for Medicare & Medicaid Services

COVID-19

Department of Health and Human Services

COVID-19 Update

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Learn more from the following resources:

– an FDA news release;

– revised prescribing information for remdesivir;

– the revised emergency use authorization for the drug; and

– a revised FDA FAQ on remdesivir.

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

National Institutes of Health

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Congressional Budget Office (CBO)

Stakeholder Events

NIH National Institute of Nursing Research – January 25

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

 

 

Federal Health Policy Update for 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 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 Ypdate for Tuesday, December 21

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, December 21.  Some of the language used below is taken directly from government documents.

The White House

The administration has announced new steps to protect Americans and help communities and hospitals battle the COVID-19 omicron variant.  The major parts of this initiative include:

  • Increasing support for hospitals by deploying 1000 Department of Defense medical personnel to hospitals during January and February and federal medical personnel to some states immediately; expanding hospital capacity; providing support to states to help hospitals create and license more beds; deploying hundreds of ambulances and emergency medical teams to transport patients to available hospital beds; and providing critical supplies, including supplies from the Strategic National Stockpile and ventilators, to states.
  • Ensuring access to free testing, including by launching new federal testing sites; distributing free rapid tests to Americans after purchasing 500 million such tests, with delivery expected beginning in January; and employing the Defense Production Act to accelerate test production.
  • Expanding capacity to administer COVID-19 vaccines, including by establishing new pop-up vaccination clinics, deploying additional vaccinators, giving flexibility to surge pharmacy teams, and continuing to scale pharmacy capacity.

Learn more from this White House news release.  In addition, the White House held a background briefing for the press prior to the announcement to offer further details.  Go here for a transcript of that briefing.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS has released a final rule with comment period announcing several proposed policies that were not addressed in the final Medicare inpatient prospective payment system rule for FY 2022.  Among these proposals was CMS’s implementation of the Consolidated Appropriations Act of 2021 distribution of 1000 new graduate medical education residency positions for hospitals over the next five years and CMS’s proposal to change the calculation of “Medicare usable organs” when determining acquisition costs for which Medicare will reimburse transplant hospitals.  Learn more from this CMS news release and an accompanying CMS fact sheet.

Department of Health and Human Services

Health Policy Update

  • HHS’s Agency for Healthcare Research and Quality’s (AHRQ) software tools for the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) are updated annually to accommodate new or revised ICD-10-CM/PCS codes and to add corrections or modifications based on new clinical guidance for the use of those codes.  Go here for the updated codes for FY 2022.
  • HHS and its Office for Civil Rights have issued guidance to help clarify how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers to disclose protected health information to support applications for extreme risk protection orders that temporarily prevent a person in crisis from gaining access to firearms.  Find HHS’s announcement about the new guidance here and find the guidance itself here.
  • HHS has announced that it will spend $282 million to help transition the National Suicide Prevention Lifeline from its current 10-digit number to a three-digit dialing code:  988.  The agency will spend $177 million to strengthen and expand the existing Lifeline network operations and telephone infrastructure and $105 million to build up staffing across states’ local crisis call centers.  Learn more from this HHS announcement.
  • HHS’s HIV/AIDS Bureau has released the 2020 Ryan White HIV/AIDS Program Annual Client-Level Data Report.  Find the report here.  The bureau also has released 2020 Ending the HIV Epidemic in the U.S. Initiative (EHE) Data Report, which can be found here

COVID-19

  • HHS announced that 15 digital health start-ups are joining its 2022 PandemicX Accelerator cohort to address health inequities, create a culture for success, and deploy resources to mitigate the effects of the COVID-19 pandemic.  PandemicX will be co-led by the Office of the Assistant Secretary for Health and the Office of the National Coordinator for Health IT and involves using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.  Learn more about the project and find a list of participating organizations in this HHS announcement.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC executive director Anne L. Schwartz, PhD will retire in the spring of 2022.  She has led the organization for nearly a decade.  See the MACPAC announcement here

 

Federal Health Policy Update for Thursday, December 16

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

Provider Relief Fund

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

The White House

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

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

Centers for Disease Control and Prevention

Food and Drug Administration

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

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Government Accountability Office (GAO)

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

Federal Health Policy Update for Thursday, December 9

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

Update on Efforts to Delay Medicare Sequestration Cuts

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

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

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

The White House

Centers for Medicare & Medicaid Services

Health Policy Update

Department of Health and Human Services

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

National Institutes of Health

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

Stakeholder Events

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  The two days of meetings will consist of four separate sessions.  For agendas for those sessions and information on how to register to participate, go here.

MACPAC – commission meeting – December 9-10

Members of the Medicaid and CHIP Payment and Access Commission will meet virtually on December 9 and 10.  To see the meeting agenda and register to participate, go here.

 

Federal Health Policy Update for Monday, December 6

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

NASH Advocacy

  • NASH has submitted formal comments to the Department of Health and Human Services, Department of Labor, Department of the Treasury, and federal Office of Personnel Management in response to those agencies’ publication of a second regulation describing how the No Surprises Act will be implemented. In its letter NASH focuses on problems with the manner in which providers will be required to prepare good-faith estimates for those seeking care without benefit of insurance, the regulation’s Independent Dispute Resolution process, and the manner in which the regulation addresses resolving fee disputes between providers and patients.  NASH raises concerns about all of these processes, suggests better approaches to addressing them, and asks the federal agencies to suspend enforcement of the new requirements while they consider ways to improve the current approach to implementing the surprise billing law that was enacted late last year.  Go here to read NASH’s comment letter.

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has announced that it will require states to cover COVID-19 vaccine counseling during which health care providers talk to families about the importance of vaccines for children. Under this policy CMS will now consider certain COVID-19 vaccine counseling visits for children and youth to be COVID-19 vaccine administration for which state expenditures can be federally matched at 100 percent through the last day of the first quarter that begins one year after the end of the COVID-19 public health emergency.  CMS will match COVID-19 vaccine counseling-only visits at the 100 percent federal match rate only when they are provided to children and youth under age 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.  Learn more from this CMS news release.
  • CMS has announced a series of steps it will take to encourage Medicare beneficiaries to receive COVID-19 vaccines. Read about these steps in this CMS news release.

Health Policy Update

Department of Health and Human Services

Health Policy Update

  • A new HHS report found a significant increase in the use of telehealth during the COVID-19 pandemic, with specialists like behavioral health providers seeing the highest telehealth utilization relative to other providers. The report found that the share of Medicare visits conducted through telehealth in 2020 increased 63-fold, from approximately 840,000 in 2019 to 52.7 million.  States with the highest use of telehealth in 2020 included Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut while states with the lowest use of telehealth that year were Tennessee, Nebraska, Kansas, North Dakota, and Wyoming. The report also identified trends in the kinds of services Medicare beneficiaries sought through telehealth.  Learn more from this HHS news release and go here to see the report itself.

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

CMS – Open Door Forum on No Surprises Act – December 8

CMS will host an open door forum to discuss provider requirements under the No Surprises Act on Wednesday, December 8 at 2:00 p.m. (eastern).  The forum will be held by conference call only and interested parties can dial into the event at 1-888-455-1397; the conference ID is 8604468.

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

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

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

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

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  The two days of meetings will consist of four separate sessions.  For agendas for those sessions and information on how to register to participate, go here.

MACPAC – commission meeting – December 9-10

Members of the Medicaid and CHIP Payment and Access Commission will meet virtually on December 9 and 10.  To see the meeting agenda and register to participate, go here.

Federal Health Policy Update for Wednesday, December 1

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

Omicron Variant

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

Health Care Employee Vaccine Mandate

COVID-19

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

No Surprises Act

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

The White House

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy Update

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

Department of Health and Human Services

Health Policy Update

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Stakeholder Events

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

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

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

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

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

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

MEDPAC – commission meeting – December 9-10

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