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 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 Friday, November 19

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

Congress

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

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

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

This new spending would be paid for in part by:

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

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

The White House

Provider Relief Fund

  • HHS’s Health Resources and Services Administration, which administers the Provider Relief Fund, has established a 60-day grace period for complying with the fund’s Reporting Period 1.  The grace period began on October 1, 2021, and will end on November 30, 2021 at 11:59 p.m. (eastern).  Learn more here, under “60-Day Grace Period – Reporting Period 1.”

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy Update

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

Department of Health and Human Services

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

National Institutes of Health

Occupational Safety and Health Administration (OSHA)

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

Government Accountability Office (GAO)

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

Stakeholder Events

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

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

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

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

MedPAC Looks at Outpatient Payments

The question of whether Medicare should pay different rates for outpatient services delivered in different types of settings was very much on the minds of Medicare Payment Advisory Commission members during their public meetings last week.

The issue has been around for a while:  are there valid reasons for some facilities to be paid more for certain outpatient services than other facilities?  Or should the payment rate for a given service be the same regardless of where that service is delivered?  Does the site of the service matter – or should it?

At issue are Medicare payments made to private physician offices, hospital outpatient departments, and ambulatory surgical centers and whether they should be adjusted based on some of the underlying costs associated with those facilities or the matter of who owns them – or whether a service is a service that should be reimbursed at the same rate regardless of where it is delivered.  Underlying this issue is whether providers should be compensated for such services through Medicare’s outpatient prospective payment system or its physician fee schedule.

It matters where MedPAC ultimately comes down on this issue.  While the agency’s primary role is to advise Congress on Medicare payment issues, its views are highly respected in health policy circles and often find their way into new public policies.

Learn more about the issues involved and what MedPAC commissioners think about them in the MedPage Today article “Should Medicare Pay the Same Amount Regardless of Where a Service Is Provided?

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.

Federal Health Policy Update for Tuesday, October 19

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, October 19.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Reminder That Applications Are Now Being Accepted

  • The Health Resources and Services Administration (HRSA) has opened its portal for providers to apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants, for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application deadline is October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

  • HHS has renewed its declaration of a public health emergency because of the COVID-19 pandemic.  It now extends until January 16, 2022.
  • HHS’s Office of the Inspector General (OIG) performed an audit to identify actions that selected states took or planned to take to ensure that Medicaid beneficiaries continued to receive prescription drugs during the COVID-19 pandemic.  Find its audit report here.
  • HHS’s OIG has updated its work plan to add a review of nursing home reporting of COVID-19 data to the National Healthcare Safety Network.  Go here to see the updated OIG work plan and here for additional information about the new review.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public to inform its review of telehealth during COVID–19.  For more information about the kind of input the agency seeks, see its request for information notice in the Federal Register.  The deadline for submissions is November 12.
  • On Thursday, September 30, the COVID-19 Health Equity Task Force held its seventh public meeting to vote on a final slate of recommendations for mitigating health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.  For a summary and links to video of the meeting, go here.

Health Policy News

  • HHS has announced the availability of $100 million in American Rescue Plan funding for state-run programs that support, recruit, and retain primary care clinicians who live and work in underserved communities.  This funding seeks to help improve health equity by ensuring that clinicians working in high-need communities remain in them.  HHS’s Health Resources and Services Administration’s Bureau of Health Workforce is accepting applications for these grants from all 50 states, Washington D.C., and U.S. territories.  HRSA estimates it will make up to 50 awards of up to $1 million a year over the program’s four-year project period.  Learn more about the funding from this HHS announcement and go here to learn about HRSA’s State Loan Repayment Program.  Applications are due April 8, 2022.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest installment of MLN Connects, its online newsletter.  The new edition includes articles about submitting claims for pneumonia vaccines, correct billing practices for non-physician outpatient services provided during or shortly after inpatient stays, changes in the Laboratory National Determination Edit Software for January of 2022, and more.  Find it all here.
  • CMS’s Center for Medicare and Medicaid Innovation has published evaluations of three model programs:  the Maryland Total Cost of Care Model, the Vermont All-Payer Accountable Care Organization Model, and the Pennsylvania Rural Health Model.  Find the new evaluations here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has awarded 11 new clinical trial research grants worth more than $25 million over the next four years through its Orphan Products Grants Program to clinical investigators to support the development of medical products for patients with rare diseases.  Learn more about the grant recipients and the research they are pursuing in this FDA news release.
  • The FDA has approved an abbreviated new drug application for propofol injectable emulsion single patient-use vials.  This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database that is used in the treatment of COVID-19 patients.  Learn more from the FDA announcement.

National Institutes of Health

  • The NIH has published preliminary technical research on the effectiveness of mixing different sources of COVID-19 vaccines when receiving booster shots.
  • The NIH reports that a clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia.  In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes.  Learn more in this NIH news release.
  • New NIH-funded research suggests how certain treatments are effective for patients with COVID-19 who develop multisystem inflammatory syndrome in children (MIS-C).  Learn more in this NIH news release.
  • The NIH announced that it has issued contract awards totaling $77.7 million to develop and manufacture new rapid diagnostic tests for COVID-19.  The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections.  Learn more from this NIH news release.
  • The NIH has awarded 11 grants worth $58 million over five years to focus on interventions to address health disparities and advance health equity.  The grants were awarded based on the significance of the research problem, the novelty of the idea or approach, and the magnitude of the potential impact rather than on preliminary data or experimental details.  Learn more from this NIH news release.

Department of Education

  • The Department of Education has introduced a new resource, which it calls “Supporting Child and Student Social, Emotional, Behavioral and Mental Health,” that outlines key challenges in providing and accessing mental health supports in schools and provides evidence-based recommendations for educators, staff, and providers to create a system of supports for students with behavioral health needs and their families.  Learn more from this White House fact sheet and from the publication Supporting Child and Student Social, Emotional, Behavioral and Mental Health.

National Academies of Sciences, Engineering, and Medicine

  • The National Academies of Sciences, Engineering, and Medicine has published advice for talking to parents about getting their children vaccinated against COVID-19.  Learn more from this news release.

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 21

The Health Resources and Services Administration will hold web events on Thursday, October 21 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking such grants.  To register for the October 21 webcast, go here.

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

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

Federal Health Policy Update for Tuesday, September 21

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

NASH Advocacy

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

Provider Relief Fund

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

The White House

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

National Institutes of Health

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

Stakeholder Events

MACPAC – September meetings – September 23 and 24

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

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

Federal Health Policy Update for Monday, September 13

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, September 13.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS and its Health Resources and Services Administration (HRSA) are making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan money for providers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients and an additional $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that can document revenue loss and expenses associated with the pandemic.  To learn more about the funding to be distributed and how it will be distributed, see the following resources:

NASH members received a more detailed explanation about the availability of these funds last Friday, September 10.

The White House

Department of Health and Human Services

COVID-19

  • HHS has amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to provide a pathway for increased access to COVID-19 therapeutics – specifically, monoclonal antibodies – especially in surge states with rising numbers of COVID-19 cases and in rural areas where access to inpatient and outpatient services may be more limited.  For more information about the health care professionals to which these protections have been extended and about the protections themselves, see this HHS announcement.  This amendment of the PREP Act also will be published in the Federal Register; go here to see a pre-publication version of the Federal Register notice.

Health Policy News

  • HHS, the departments of Labor and the Treasury, and the Office of Personnel Management have proposed rules that would require health plans, issuers, and providers of air ambulance services to submit detailed data regarding air ambulance services specified in the reporting requirements of the No Surprises Act.  The rules also outline CMS’s authority to fully enforce Title I (the No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act of 2021 in states that do not have the authority to enforce or fail to substantially enforce one or more of the provisions and seek to help consumers understand the compensation being paid to agents and brokers who help them select health insurance.  This is the latest regulatory action in a series of rulemaking implementing the No Surprises Act.  Learn more from the following resources:
  • HHS is awarding $20 million in American Rescue Plan grant funding to state-based marketplaces to increase consumer access to affordable, comprehensive health insurance coverage.  The grants will be used by 21 state-based marketplaces to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment simpler.  Learn more about how the money will be used and which state-based marketplaces will receive it in this HHS announcement.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide support to communities and health care providers to help combat the overdose epidemic.  Grants are being awarded through six existing programs:  Medication Assisted Treatment for Prescription Drug and Opioid Addiction; Tribal Opioid Response Grants; Screening, Brief, Intervention, and Referral to Treatment; Strategic Prevention Framework for Prescription Drugs; First Responder-Comprehensive Addiction and Recovery Act Grants; and Providers Clinical Support System – Universities.  Learn more about where the money will go and how it will be spent in this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • The administration announced that it will require COVID-19 vaccination of staff in all Medicare- and Medicaid-certified facilities.  CMS, in collaboration with the CDC, announced that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.  Go here to find an explanation of the new policy.

Health Policy News

  • CMS announced that it is rescinding audit determinations for providers notified in January of 2021 that they had failed to qualify for what is known as the “mid-build exception.”  The Bipartisan Budget Act of 2015 changed how off-campus provider-based departments are paid for items and services furnished to Medicare beneficiaries.  CMS will review each previously failing provider’s audit findings for compliance with statutory requirements and for accuracy and completeness and providers that received failing audit determinations are no longer required to report or return overpayments based on those determinations.  Each provider will receive a letter rescinding the previous determination.   An updated audit determination letter will be issued following the review of each provider’s audit.  A new overpayment return deadline for self-identified overpayments will be included in that letter should the provider receive a failing audit determination.  Learn more from this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.  The drug is often used on COVID-19 patients who need ventilators.  See the FDA’s announcement.

Stakeholder Events

 CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.