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 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 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 Monday, November 15

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, November 15.  Some of the language used below is taken directly from government documents.

The White House

Centers for Medicare & Medicaid Services – Final Guidance on Shared/Co-Located Hospital Spaces

  • In a memo to state survey agencies, CMS has published final guidance for the evaluation of compliance with the Medicare Conditions of Participation that address shared space and services for hospitals co-located with other hospitals or health care entities, updating guidance issued in May of 2019.  The revised guidance is shorter and less prescriptive and does not contain nearly as much detail as the 2019 draft.  Find it here.

Centers for Medicare & Medicaid Services

COVID-19

  • In a memo to state survey agencies, CMS has revised restrictions on nursing home visits, easing limits it introduced last year in an attempt to limit the spread of COVID-19.  Find the new guidance here.
  • A second CMS memo to state survey agencies on the subject of nursing homes suggests steps those agencies can take to address the backlog of facility complaint and recertification surveys that has amassed during the pandemic.  Find that memo here.

Health Policy Update

  • CMS has published the latest edition of MLN Connects, its online newsletter about Medicare reimbursement matters.  The new update has articles about CMS’s provider enrollment application fee for CY 2022, updates in the long-term hospital (LTCH) and inpatient rehabilitation facility (IRF) quality reporting programs for 2022, billing for durable medical equipment provided during inpatient stays, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released its Medicare Part A and Part B premiums for calendar year 2022.  The Part B increase is one of the largest in years, which CMS attributes to the possibility that it may be required to provide coverage for the use of the new Alzheimer’s treatment drug Aduhelm.  Learn more about 2022 Part A and Part B premiums and Medicare coverage changes in this CMS news release and an accompanying CMS fact sheet.
  • CMS has repealed a regulation adopted in January of this year titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and Necessary’” that established faster access for Medicare beneficiaries to recently authorized medical devices designated as breakthroughs by the FDA.  See the repeal notice and read CMS’s rationale for its action in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • HHS has withdrawn a policy that directed the FDA not to enforce pre-market review requirements for laboratory-developed tests.  The FDA also updated its policies regarding tests, including laboratory-developed tests, currently being offered prior to or without authorization as well as policies regarding the types of tests on which the FDA intends to focus its reviews in the future.  Go here to see the FDA announcement about this change and its future priorities and go here to read a statement from HHS Secretary Xavier Becerra outlining his rationale for the change.

National Institutes of Health

  • The NIH has enrolled the first participants in a study that will track up to 1000 children and young adults who previously tested positive for COVID-19 and evaluate the impact of COVID-19 on their physical and mental health over three years.  Learn more from this NIH announcement.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • In September of this year the Senate Finance Committee requested input on opportunities to enhance behavioral health care in the areas of strengthening the workforce; increasing integration, coordination, and access; ensuring parity between behavioral health and physical health care; furthering the use of telehealth; and improving access to behavioral health care for children and young people.  In its response to this request, MACPAC urges the committee to address the needs of adults and children enrolled in Medicaid and CHIP.  In addition, it stresses the need to address barriers to care that result in disparities in access to care and behavioral health outcomes for Black, Hispanic, and Asian American beneficiaries, people with disabilities, and those living in rural areas.  Go here to see MACPAC’s full response.

Stakeholder Events

CMS – Hospital/Quality Imitative Open Door Forum – November 17

CMS will hold a Hospital/Quality Initiative Open Door Forum on Wednesday, November 17 at 2:00 p.m. (eastern).  The forum will address a number of issues, including the CY 2022 hospital outpatient prospective payment system and ambulatory surgical center payment system final rule, outpatient payments, pass-through drugs and devices, ambulatory surgical center payments, hospital price transparency, and the Radiation Oncology Model.  This forum will be held by conference call.

To participate, dial 1-888-455-1397 and use conference passcode 8604468

HHS/Center for Medicare and Medicaid Innovation – November 18

On Thursday, November 18 HHS’s Center for Medicare and Medicaid Innovation will host a webinar listening session at 1:00 p.m. (eastern) as a follow-up to the release of its recently published document “Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade.”  The listening session will be an opportunity for stakeholders to share with CMS leaders their perspectives on how to execute the agency’s strategic vision.  Register for the event and find more information here.

CDC/NIOSH – Mental Health of the Health Care Workforce – November 18

On Thursday, November 18 the CDC’s National Institute for Occupational Safety and Health (NIOSH) will host a virtual event with NIOSH director Dr. John Howard, Surgeon General Dr. Vivek Murthy, and other national experts from labor and medicine on the mental health of the nation’s critical health workforce.  Go here to learn more about the participants and the subjects they plan to address and go here to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

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

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

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

Federal Health Policy Update for Thursday, November 4

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

New Federal Vaccination Requirements

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

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

New Medicare Regulations

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

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

The White House

Congress

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

Provider Relief Fund:  Phase 3 Payment Reconsideration

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

Department of Health and Human Services

Health Policy News

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

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

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

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy News

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

Food and Drug Administration

Centers for Disease Control and Prevention

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Government Accountability Office (GAO)

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

Congressional Research Service

Stakeholder Events

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

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

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

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

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

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

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

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

CDC – Antibiotic Prescribing and COVID-19 – November 18

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

Innovation Center Unveils Blueprint

The CMS Innovation Center has published a document that shares its strategic direction for the coming years.

Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten:

  • Drive Accountable Care – increase the number of people in a care relationship for quality and total cost of care.
  • Advance Health Equity – embed health equity in every aspect of CMS Innovation Center models and increase focus on underserved populations.
  • Support Care Innovation – leverage a range of supports that enable integrated, person-centered care such as actionable, practice-specific data, technology, dissemination of best practices, peer-to-peer learning collaborations, and payment flexibilities.
  • Improve Access by Addressing Affordability – pursue strategies to address health care prices, affordability, and reduce unnecessary or duplicative care.
  • Partner to Achieve System Transformation – align policies and priorities across CMS and aggressively engage payers, purchasers, providers, states, and beneficiaries to improve quality, to achieve equitable outcomes, and to reduce health care costs.

In addition, the document summarizes the lessons the CMS Innovation Center has learned over the past ten years, outlines future approaches to assessing the agency’s impact, and presents an implementation strategy for the coming years.

Learn more about what the CMS Innovation Center has in mind for providers, payers, and patients in the agency’s new document Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade and find a summary of the document here.

Changes Coming in Innovation Center Payment Models

Future Medicare payment models will probably feature less risk for participants and a greater emphasis on health equity.

At least that is the vision shared by Centers for Medicare & Medicaid Services chief operating officer Jon Blum during a recent conference.

While not backing away from including risk in future value-based purchasing models, CMS and the Center for Medicare and Medicaid Innovation Center will probably propose fewer full-risk models, which the agency fears favor wealthier providers that can afford to shoulder more risk to begin with, and a greater focus on reporting race and ethnicity data among future model participants as the federal government works to close equity gaps.

In addition, CMMI will probably simplify its array of payment models and have fewer tracks within those models.

Learn more about the directions CMMI envisions moving with its Medicare alternative pay models in the near future in the Fierce Healthcare article “CMS official:  Don’t expect a lot of fully risk-based payment models going forward.”

Federal Health Policy Update for Thursday, July 22

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, July 22.  Some of the language used below is taken directly from government documents.

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published its proposed calendar year 2022 Medicare outpatient prospective payment system regulation.  Among other subjects, the proposed regulation addresses hospital outpatient and ambulatory surgery center payment rates, hospital price transparency, the section 340B prescription drug discount program, changes in the inpatient-only list and ambulatory surgery center covered procedures list, changes in the hospital outpatient and surgery center quality reporting programs, the newly created rural emergency hospital provider type, the Radiation Oncology Model, temporary flexibilities implemented to facilitate the response to COVID-19, and more.  Stakeholder comments are due by September 17.  Learn more from the following resources.
  • CMS’s Center for Medicare and Medicaid Innovation has updated the web page of its Radiation Oncology Model to reflect changes in the program addressed in the newly published proposed Medicare outpatient prospective payment system regulation.  The updated web page includes links to additional resources about the Radiation Oncology Model.
  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes a description, billing information, a fact sheet, and more for the monoclonal antibody tocilizumab, which recently received FDA emergency authorization for use in treating COVID-19 patients; information on ICD-10-CM codes for FY 2022; a change in the national coverage for a (CAR) T-cell therapy; and more.  For this and more, go here.
  • CMS has published an advisory to alert certain clinicians who are qualifying alternative payment model (APM) participants and eligible to receive APM incentive payments that CMS does not have the current billing information it needs to send them their payments.  The advisory tells these clinicians how to update their billing information to receive their payments.  Affected physicians must submit updated billing information by November 1.  Read the notice here.
  • CMS has released an informational bulletin informing states that the Department of Homeland Security’s  2019 public charge rule has been vacated and is no longer in effect.  The notice explains that effective March 9, 2021, the Department of Homeland Security started applying the 1999 interim field guidance for public charge inadmissibility determinations, which is the policy that was in place before the 2019 public charge final rule.  Under that 1999 guidance, that agency will not consider an individual’s receipt of Medicaid benefits as part of the public charge determination except for individuals who are institutionalized on a long-term basis (such as nursing facility residents) and are receiving Medicaid coverage for their institutional services.  HHS has published a news release with the same information.

Department of Health and Human Services

COVID-19

  • HHS has renewed for 90 days its declaration of the public health emergency caused by COVID-19.
  • HHS will spend more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.  $100 million will be spent to expand dedicated testing and mitigation resources for people with mental health and substance use disorders; $80 million will go to support state and local COVID-19 testing and mitigation measures among people experiencing homelessness, residents of congregate settings including group homes and encampments; and $169 million will be spent for testing and mitigation in federal prisons.  Learn more from the HHS news release.
  • HHS has distributed nearly $100 million in American Rescue Plan money to rural health clinics to support outreach efforts to increase vaccinations in their communities.  The funds will go to nearly 2000 Rural Health Clinics, which will use these resources to develop and implement additional vaccine confidence and outreach efforts in medically underserved rural communities.  See HHS’s news release for more information and for a link to a list of how much money was distributed on a state-by-state basis.

Health Policy News

  • HHS’s Health Resources and Services Administration (HRSA) has announced a change in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank.  The new fee will be $2.50 for both continuous and one-time queries and $3.00 for self-queries.  Learn more about this increase and other changes in use of the National Practitioner Data Bank in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has formally accepted Pfizer’s application for full approval of its Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review.  Currently, the vaccine is authorized for emergency use in individuals ages 12 and older.  Learn more here.

Government Accountability Office

Medicaid and CHIP Payment and Access Commission (MACPAC)

State Medicaid programs are required to cover certain mental health services for adults while other mental health services are optional.  In a new compendium, MACPAC documents coverage of selected mental health services available to Medicaid beneficiaries in each state and the District of Columbia.  Find a link to the report here.

Stakeholder Events

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

Wednesday, August 4 at 2:00 – 3:00 pm ETClick here for more information

ZOHU Calls are one-hour monthly webinars that provide timely education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

Monday, August 23 from 9:30 a.m. to 5:00 p.m. (eastern)

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually to advise the agency about the clinical integrity of the Ambulatory Payment Classification groups and their associated weights and about supervision of hospital outpatient therapeutic services.  The advice provided by the panel will be considered as CMS prepares its annual updates for the hospital outpatient prospective payment system.

The public may participate in this meeting by webinar or teleconference.  Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted here when available.

 

New Health Care Leaders Share Priorities

New leaders at the Centers for Medicare & Medicaid Services and the Center for Medicare and Medicaid Innovation are quickly making their priorities known to health care industry stakeholders.

For new CMS administrator Chiquita Brooks-LaSure, her priority is coverage.  She has declared that “Our focus is going to be on making sure regulations and policies are going to be focused on improving coverage,” and while she hopes that states that have not yet expanded their Medicaid programs will take advantage of current federal incentives to do so, there is another path to coverage:  “…the public option or other coverage certainly would be a strategy to make sure people in those states have coverage.”

For new CMMI director Liz Fowler, one of her stated objectives is to make more value-based payment models mandatory rather than voluntary, noting that “What we have learned from CMMI models over the past 20 years is that voluntary models [are] subject to risk selection, which has a negative impact on the ability to generate system-level savings.”  To that end, Fowler said she and CMMI are exploring more mandatory models.

Learn more about the directions new federal health care leaders hope to take their operations in the Kaiser Health News article “Expanding Insurance Coverage is Top Priority for New Medicare-Medicaid Chief” and the Fierce Healthcare article “CMMI director:  expect more mandatory value-based care payment models.”

CMS Reconsidering Medicare Payment Models

Five Medicare alternative payment models previously slated for implementation are being delayed, cancelled, or reconsidered.

The five APMs whose futures are not clear are:

  • The Community Health Access and Rural Transformation Model ACO Track
  • Primary Care First
  • Kidney Care Choices
  • Geographic Direct Contracting
  • Part D Payment Modernization Model

Learn more about the Centers for Medicare & Medicaid Services’ latest actions on these models in the Becker’s Hospital Review article “5 CMS payment models that are under review, delayed.”