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.

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, October 12

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, October 12.  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 period runs for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has launched a Spanish version of its QuestionBuilder app, which can help Latino patients prepare for their in-person or telehealth appointments.  Go here to learn more about the app and its features.
  • HHS’s Office of the National Coordinator for Health Information Technology has launched a new initiative called USCDI+ to support the identification and establishment of domain- or program-specific datasets that will operate as extensions of the existing USCDI.  In particular, USCDI+ is a service that ONC will provide to federal partners that seek to establish, harmonize, and advance the use of interoperable datasets that extend beyond the core data in the USCDI to meet agency-specific programmatic requirements.  Learn more from ONC’s USCDI+ web page.
  • HHS has released its Climate Adaptation and Resilience Plan to bolster the resilience of its operations and assets from the accelerating impacts of climate change.  The plan provides a road map for assuring that all parts of the department address the threats to health and well-being related to climate change for all people in the United States, especially those most vulnerable. The plan also ensures continuity of operations of HHS facilities in the face of extreme weather events and fosters healthy greenhouse gas reduction and resilience efforts in the public health sector and community.  Learn more about the plan from this HHS news release, the plan itself, and an HHS policy statement about the plan.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 frequently asked questions on Medicare fee-for-service billing with new information about the application of the revised definition of “direct supervision” to the work of physical therapists and occupational therapists.  Find the new information here, on page 172.
  • CMS has updated its COVID-19 emergency declarations blank waivers for health care providers to waive certain requirements for Medicare-dependent hospitals for the rest of the official public health emergency period.  See the new information on page 12 of the blanket waivers document.

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online newsletter covering Medicare policy.  The new edition includes articles about a modification of the Medicare-dependent hospital waiver, a quarterly update of the end-stage renal disease prospective payment system, FY 2022 updates of the inpatient psychiatric facilities prospective payment system, new claims-based measures added to the hospice quality reporting program, and more.  Find the new edition of MLN Connects here.
  • CMS has released its 2022 star ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans to help people with Medicare compare plans ahead of Medicare open enrollment, which begins on October 15.  Learn more about the star ratings and find additional resources in this CMS news release.
  • CMS has issued a new report describing what Z codes for social determinants of health revealed about Medicare fee-for-services beneficiaries in 2019.  Find the report here.

Centers for Disease Control and Prevention

National Institutes of Health

  • More than 140,000 children in the U.S. have lost a primary or secondary caregiver because of COVID-19, the NIH reports.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC met last week.  Issues on its agenda included addressing the high prices of pharmaceutical products and other technologies covered by Medicare; data on Medicare’s net prices for prescription drugs and other drug pricing metrics; a report for Congress on vulnerable Medicare beneficiaries’ access to care; features of Medicare’s alternative payment models; improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions; and the Medicare hospital wage index.  Go here to find the briefs and presentations used to guide the commissioners’ discussions; a transcript should appear at this site as well later this week.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 13 and 21

The Health Resources and Services Administration will hold web events on Wednesday, October 13 and 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 13 webcast, go here.
  • To register for the October 21 webcast, go here.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13 and October 14

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 and October 14.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

Federal Health Policy Update for Thursday, September 9

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

The White House

Congress

  • Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill.  Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more.  Find their summary of their proposals here.

Provider Relief Fund

  • HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency.  Find the notice here.
  • With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements.  For information about how to join the event and more about reporting and auditing requirements, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices.  One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.  Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
  • The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies.  This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies.  $20 million in grants will be awarded, with a maximum grant of $4 million.  The deadline for applications is September 22.
  • HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies.  Find the updated information here.
  • The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
  • HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19.  The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19.  Find the report here.
  • Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted two new editions of MLN Connects, its online newsletter.  Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more.  Go here to see the September 2 edition of MLN Connects.
  • The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more.  Find the September 9 edition of MLN Connects here.
  • CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers.  As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage.  States also will have more pass-through funding to implement their waiver.  Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model.  Go here to see the annual report and here for more information about and resources for the program.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together.  The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent.  The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
  • The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older.  Learn more here.

National Institutes of Health

  • An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation.  Find its letter here.
  • MedPAC’s commissioners met last week for two days to discuss Medicare payment issues.  During the meetings MedPAC addressed the following issues:
    • The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
    • Potential reforms of the Part D low-income premium subsidy.
    • A report on designing a value incentive program for post-acute care.
    • A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.

For briefs and presentations on these subjects go here; for a transcript of the MedPAC meetings go here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

  • The AMA has announced eight new CPT codes for COVID-19 vaccine administration.  Learn more from this AMA notice.
  • The AMA has issued its annual update of CPT codes.  The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions.  Learn more from this AMA news release.

Stakeholder Event

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 4:05 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

 

Federal Health Policy Update for Thursday, August 19

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

The White House

Provider Relief Fund

Centers for Medicare & Medicaid Services

COVID-19

  • CMS and the CDC are developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare- and Medicaid-participating nursing homes.  In announcing this new policy, CMS notes that “About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%.  The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.”  Learn more from the CMS announcement.
  • CMS has published a special edition of its online newsletter, MLN Connects, that presents information about codes and payments for the additional doses of COVID-19 vaccinations authorized by the FDA last week for selected at-risk individuals.  The American Medical Association has published similar information.
  • CMS has invited eligible Medicaid managed care organizations to participate in a data-sharing pilot project to facilitate increased care coordination for individuals dually eligible for Medicare and Medicaid during the COVID-19 emergency.  This pilot project is open to a maximum of 20 Medicaid managed care organizations that enroll dually eligible beneficiaries.  The application deadline is August 30.  Learn more about the program here.

Health Policy News

  • The Most Favored Nation Model introduced by CMS’s Center for Medicare and Medicaid Innovation (CMMI) sought to test a new 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.  In the face of legal challenges that prevented implementation of the program as proposed, CMMI has announced that it will not implement the program without additional rulemaking.  Go here to learn more about the program and its change in status.
  • CMS has published the latest edition of its MLN Connects, its online newsletter.  This week’s edition includes features on updated web-based training on Medicare fraud and abuse prevention, detection, and reporting; webinars on Medicare ground ambulance data collection; updated instructional resources for inpatient rehabilitation facility and long-term-care hospital Quality Reporting Program documents; and more.

Department of Health and Human Services

COVID-19

Health Policy News

  • A study by HHS’s Office of the Inspector General has concluded that Medicare pays three times as much for the capital costs of new hospitals during their first two years of existence – an average of $1.3 million a year more – than it pays established hospitals for their capital costs.  The OIG recommended that CMS reevaluate this policy.  CMS concurred with the OIG’s recommendation.  Learn more from the OIG study.
  • HHS has awarded $19 million in grants to 36 recipients to strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nation-wide.  Learn more about the specific grant recipients and the purposes for which they received awards in this HHS announcement.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

Medicaid and CHIP Payment and Access Commission (MACPAC)

Government Accountability Office (GAO)

Stakeholder Events

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.

Federal Health Policy Update for Friday, July 16

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

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS is providing notifications to facilities that were determined to be out of compliance with Quality Reporting Program (QRP) requirements for CY 2020, which will affect their FY 2022 Annual Payment Update (APU).  Non-compliance notifications are being distributed by the Medicare Administrative Contractors (MACs) and were placed into facilities’ CASPER folders in QIES, for Hospice and SNFs, and into facilities’ My Reports folders in iQIES for IRFs and LTCHs onJuly 14, 2021.  Facilities that receive a letter of non-compliance may submit a request for reconsideration to CMS via email no later than11:59 pm on August 13, 2021. Facilities that receive a notice of non-compliance and would like to request a reconsideration should see the instructions in their notice of non-compliance and on the appropriate QRP webpage:
  • The Medicare Geographic Classification Review Board application is available for the FY 2023-2025 reclassification cycle.  The current application and reinstatement period is open through September 1, 2021.  MGCRB rules have been updated, effective immediately, to update several administrative items, specifically:
    • MGCRB mailing address (for use with statewide applications)
    • S. Census Bureau links in Appendix C (for most recent reference maps (March 2020))
    • clarification of Rule 3.1 to address acceptance of correspondence subsequent to submitting the initial application

Go here for MGCRB rules, frequently asked questions, and electronic filing support.

Provider Relief Fund

  • The “reporting requirements and auditing” section of the Provider Relief Fund web page has been updated.  The Provider Relief Fund FAQ page also has been updated with new questions on pages 2, 14, 23, and 31.  Fund recipients should review these changes carefully.
    • One particular new question is noteworthy:  on page 31, the question asks “How do I appeal or dispute a decision made?”  The response is:  “HHS recognizes that providers may have questions regarding the accuracy of their PRF payments. HHS is developing a structured reconsiderations process to review and reconsider payment accuracy based on submitted supporting documentation.  Details regarding this process will be provided in coming weeks.”

Department of Health and Human Services

COVID-19

  • HHS has announced the availability of an estimated $103 million in American Rescue Plan funding over a three-year period to reduce burnout and promote mental health among the health workforce.  Awards will take into particular consideration the needs of rural and medically underserved communities, will seek to help health care organizations establish a culture of wellness  among the health and public safety workforce, and will seek support training that builds resiliency for those at the beginning of their health careers.  There are three funding opportunities for which HHS will accept applications:
  • Promoting Resilience and Mental Health Among Health Professional Workforce – approximately 10 awards will be made totaling approximately $29 million over three years to health care organizations to support members of their workforce.  This includes establishing, enhancing, or expanding evidence-informed programs or protocols to adopt, promote, and implement an organizational culture of wellness that includes resilience and mental health among their employees.
  • Health and Public Safety Workforce Resiliency Training Program – approximately 30 awards will be made totaling approximately $68 million over three years for educational institutions and other appropriate state, local, Tribal, public, or private non-profit entities training those early in their health careers.  This includes providing evidence-informed planning, development, and training in health profession activities to reduce burnout and suicide and promote resiliency among the workforce.
  • Health and Public Safety Workforce Resiliency Technical Assistance Center – one award will be made for approximately $6 million over three years to provide tailored training and technical assistance to HRSA’s workforce resiliency programs.

See the HHS announcement here.  To apply for the Provider Resiliency Workforce Training Notice of Funding Opportunities, visit Grants.gov.  Applications are due August 30, 2021.

  • HHS has awarded nearly $144 million in American Rescue Plan funding to 102 HRSA Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19 and enhance health care services and infrastructure in communities across the country.  LALs are community-based health care providers that provide essential primary health care services to underserved communities and vulnerable populations but do not otherwise receive HRSA Health Center Program funding.  Learn more in the HHS announcement about the funding, which also has a link to a list of grant recipients.

National Institutes of Health

  • High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health’s National Institute on Drug Abuse through the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative.  Go here to learn more.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has published its annual data book, which provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, dual-eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability.  It also examines provider settings and presents data on Medicare spending, beneficiaries’ access to care in the setting, and the sector’s Medicare profit margins, if applicable.  Find the data book here.

Congressional Research Service

  • In June the Occupational Safety and Health Administration (OSHA) promulgated an emergency temporary standard (ETS) for the prevention of the transmission of COVID-19 in health care employment settings.  OSHA has not used this authority since 1983, and the Congressional Research Service has prepared a report on what the ETS means and how it works.  Find that report here.

Stakeholder Events

Monday, July 19 – National Emergency Management Association (NEMA)

Mission-Ready Packages Workshop for Resource Providers

Monday, July 19 at 1:00 pm ET  Click here for registration

NEMA is hosting a workshop on developing mission ready packages (MRPs). MRPs are specific response or recovery capabilities that have been created to ensure the skills, capabilities, and associated costs are bundled prior to an emergency or disaster for more efficient deployment. These workshop sessions are designed for resource providers. A resource provider is any organization that is able to deploy under the Emergency Management Assistance Compact (EMAC) and that has capabilities that might be needed during an emergency response. Previous knowledge of EMAC or MRPs is not required.

Tuesday, July 20 – Health Resources and Services Administration (HRSA)

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

HRSA will host a recorded Reporting Technical Assistance session to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  To register for the July 20 session go here.

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.

 

Federal Health Policy Update for Friday, July 9

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 9.  Some of the language used below is taken directly from government documents.

White House

President Biden has issued an executive order “…to promote competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.”  Among other things, the executive order calls for closer scrutiny of corporate consolidation, maintaining that such consolidation results in a “…lack of competition [that] drives up prices for consumers.  As fewer large players have controlled more of the market, mark-ups (charges over cost) have tripled.  Families are paying higher prices for necessities – things like prescription drugs, hearing aids, and internet service.”  The order also includes a provision that “… enforcement should focus in particular on labor markets, agricultural markets, healthcare markets (which includes prescription drugs, hospital consolidation, and insurance), and the tech sector.”

In a section on hospitals, the order notes that

Hospital consolidation has left many areas, especially rural communities, without good options for convenient and affordable healthcare service.  Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market.  Since 2010, 139 rural hospitals have shuttered, including a high of 19 last year, in the middle of a healthcare crisis.  Research shows that hospitals in consolidated markets charge far higher prices than hospitals in markets with several competitors.

It also

  • Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.
  • Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.

Learn more from the White House fact sheet on the executive order, which addresses other aspects of health care as well.

Provider Relief Fund

  • The Provider Relief Fund’s “Reporting Requirements and Auditing” page has been updated with new information about Provider Relief Fund recipient reporting deadlines, requirements, and worksheets.  Find it here.
  • The Health Resources and Services Administration (HRSA) will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m., go here to register and for the July 20 session at 3:00 go here to register.

Department of Health and Human Services

COVID-19

  • HHS has published notice of the extension of the designation issued on February 1, 2021 identifying health and medical resources necessary to respond to the spread of COVID-19 that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies.  These designated materials are subject to the hoarding prevention measures authorized under Executive Order 13910 and section 102 of the Defense Production Act of 1950.  Learn more from the Federal Register notice.  The notice lists specific items that have had their “scarce” designation removed and others that have not.  The action took effect on July 1 and interested parties have until August 7 to submit comments.

Health Policy News

  • HHS has updated interoperability standards to support the collection and electronic exchange of data on sexual orientation, gender identity, and social determinants of health.  Learn more from HHS’s announcement about this development and from the United States Core Data for Interoperability version 2 (USCDI v2), a standardized set of health data classes and constituent data elements for nation-wide, interoperable health information exchange.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has shared a notice from the federal Cybersecurity and Infrastructure Security Agency and the FBI about how multiple managed service providers and their customers can protect themselves from recent supply-chain ransomware attacks leveraging a vulnerability in Kaseya VSA software.  Learn more here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has developed an infectious disease surge annex tabletop exercise toolkit that can be used by health care coalitions to enhance operational area awareness and capability to effectively address the needs of patients seeking care following exposure to an infectious agent.  Health care coalitions are not required to use this template but it can be used to satisfy funding opportunity announcement requirements for the hospital preparedness program cooperative agreement.  Find the toolkit and links to other resources here.
  • The same HHS office has prepared a home care and hospice emergency operations plan that includes emergency operations plans specific to home care and hospice agencies.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes an updated FAQ about repayment of COVID-19 accelerated and advance payments, including information about how recoupment works and how it affects providers’ Medicare claims payment amounts.  For this and more, including articles on updated HCPCS codes for skilled nursing facilities and updated durable medical equipment, prosthetics, orthotics, and supplies, go here.
  • CMS has announced the appointment of Dr. Meena Seshamani, M.D., Ph.D. as Deputy Administrator and Director of Center for Medicare.  Dr. Seshamani most recently served as vice president of clinical care transformation at MedStar Health, where she conceptualized, designed, and implemented population health and value-based care initiatives and served on the senior leadership of a health system with 10 hospitals and more than 300 outpatient sites.  Prior to MedStar Health, she was director of the Office of Health Reform at HHS.  Dr. Seshamani received her B.A. with honors in business economics from Brown University, her M.D. from the University of Pennsylvania School of Medicine, and her Ph.D. in health economics from the University of Oxford.  Learn more from the CMS announcement of the appointment.
  • The CMS Center for Medicare and Medicaid Innovation’s Financial Alignment Initiative is designed to provide individuals dually enrolled in Medicare and Medicaid with a better care experience and to better align the financial incentives of the Medicare and Medicaid programs.  Through this initiative, CMS partners with states to test new models for their effectiveness in accomplishing these goals.  Now, the innovation center has posted evaluation and savings reports from participating states Washington, Colorado, Minnesota, New York, and Virginia.  Find those reports and other information about the program here.

COVID-19

Centers for Disease Control and Prevention

COVID-19

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.

Food and Drug Administration

COVID-19

  • The FDA has authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.  Questions had been raised about the safety of the batch but the FDA has investigated and concluded it is safe.  See the FDA announcement of this decision here and the letter the FDA sent to JanssenBiotech explaining its decision.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has responded to the Office of Management and Budget request for information “Methods and Leading Practices for Advancing Equity and Support for Underserved Communities Through Government” with a letter that highlights opportunities for CMS and state agencies that jointly operate Medicaid and the State Children’s Health Insurance Program (CHIP) to document specific disparities in health care and develop new opportunities to improve access to and the quality of care beneficiaries receive.  The letter also outlines areas that could be addressed through subregulatory guidance, waiver opportunities, and technical assistance.  Learn more from the MACPAC letter to OMB.

National Institutes of Health

Stakeholder Events

Tuesday, July 13 – Food and Drug Administration

The FDA will host a webinar to share information and answer questions about its revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.  It will present information about its June 30, 2021 “Update:  FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.”  To join the webinar:

Zoom Webinar Link: https://fda.zoomgov.com/j/1600971341?pwd=UTJMTlZmYzVScmNZamd2d2J4SU92Zz09

Webinar Passcode: $vrC6z

Dial: 833-568-8864
Webinar ID: 160 097 1341
Passcode: 292602

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Wednesday, July 14 and Tuesday, July 20 – Health Resources and Services Administration (HRSA)

HRSA will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m. go here to register and for the July 20 session at 3:00 p.m. go here to register.

Federal Health Policy Update for Monday, June 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, June 28.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services

COVID-19

  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – Register here

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Federal Health Policy Update for Thursday, June 10

The following is the latest health policy news from the federal government as of 3:00 p.m. on Thursday, June 10.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • The White House has released a memo titled “What We Urge You To Do To Protect Against The Threat of Ransomware.”  This memo addresses the growing number and size of ransomware incidents and calls upon government and the private sector to take steps to protect their organizations from this growing threat.  The memo also outlines the federal government’s recommended best practices.  Find the memo here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about prior authorization for hospital outpatient departments, ICD-10 PCS procedure codes for FY 2022, HCPCS codes subject to and excluded from CLIA amendments, Medicare’s quarterly compliance newsletter, and more, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has written to providers to remind them that COVID-19 tests and vaccines are to be “…free for any individual living in the United States, regardless of their insurance or immigration status.”  The letter reminds providers of how they may seek reimbursement for their testing and vaccine administration costs from entities other than their patients.  See the HHS announcement of this reminder from Secretary Becerra and the letter to providers.
  • HHS announced that the federal government will purchase approximately 1.7 million courses of the investigational antiviral treatment molnupiravir (MK-4482), which is used to treat COVID-19, pending emergency use authorization or approval by the FDA.  The drug is currently in phase 3 trials.  The value of the purchase is $1.2 billion.  See the HHS announcement here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has updated its COVID-19 Behavioral Health Resources page to help address health care professional stress and resilience, including self-care resources and combating compassion fatigue.

Occupational Safety and Health Administration

  • OSHA posted a new emergency rule, soon to be published in final form, describing new steps that health care entities must take to protect their workers from COVID-19.  The steps address the use of personal protective equipment, ventilation, social distancing, time off for vaccines, and more.  Learn more from information posted on the OSHA web site and from the new emergency rule itself.  The rule takes effect upon official publication.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

  • The NIH announced that a clinical trial is under way in five U.S. cities to determine whether delivering integrated health services through mobile clinics can improve HIV and substance use outcomes among people with opioid use disorder who inject drugs.  Learn more here.

Stakeholder Events

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Friday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
FDA will present updates on the Identification of Medicinal Products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification.

Friday, June 11 – FDA
Identification of Medicinal Products:  Path to Global Implementation
Friday, June 11 at 1:00 – 2:30 pm ET   Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how the REMS safety requirements affect prescribers, dispensers and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Health Policy Update for Tuesday, June 8

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, June 8.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

COVID-19

  • The White House has posted transcripts of the June 3 and June 8 press briefings given by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • According to reports, Jon Blum will join CMS as principal deputy administrator, the same position he held during the Obama administration.  Also, Erin Richardson, currently a lobbyist for the Federation of American Hospitals, will join CMS as administrator Chiquita Brooks-LaSure’s chief of staff.  Ms. Richardson served on the White House Domestic Policy Council during the Obama administration.
  • CMS has published a guide to using the health-related social needs screening tool from the Accountable Health Communities Model.  Health-related social needs are individual-level, adverse social conditions that negatively affect individuals’ health care and are distinguished from social determinants of health.  Find the guide here.
  • CMS has issued a 2021 navigator notice of funding opportunity that will make $80 million in grant funding available to navigators in states with a federally-facilitated marketplace for the 2022 plan year.  Go here to see CMS’s announcement about the funding and go here to see formal notice of the funding opportunity.  Applications are due July 6.

Department of Health and Human Services

Health Policy News

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has issued a warning describing current vulnerabilities, including to ransomware threats, for selected health care information systems.  Find that notice here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved Aduhelm (aducanumab) for the treatment of Alzheimer’s.  Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.  Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.  Go here to see the FDA announcement and go here for further information about Aduhelm.

Medicare Payment Advisory Commission

Patient-Centered Outcomes Research Institute

  • PCORI, a non-profit organization created through the Affordable Care Act, is launching a Health Systems Implementation Initiative that it says it hopes will “…provide a channel to facilitate real-world uptake and use of evidence in healthcare delivery systems.”  To this end, PCORI has published a request for information through which it seeks “…to learn about health systems’ interest in undertaking implementation projects to improve care delivery based on findings from PCORI-funded research and related evidence.  Further, PCORI seeks feedback regarding the incentives and support that would enable health systems to undertake these activities.”  See an introduction to the project here and find the RFI here.  Questions are due by June 24 and responses are due by July 15.

Stakeholder Events

Wednesday, June 9 – FDA

Virtual Town Hall Series- Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 9 at 12:15 pm ET  Click here for connection information
FDA will host a virtual town hall for COVID-19 test developers. The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, June 10 – FEMA
COVID-19 Pandemic Operational Guidance Webinars
Thursday, June 10 at 11:00 am at 12:00 pm  ET Click here for connection information
FEMA is offering a series of webinars throughout the month of June to further educate people on the pandemic operational guidance.  The webinar will cover information included in the COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.

Thursday, June 10 – CMS

Rural Health Open Door Forum

Thursday, June 10 at 2:00 ET

Items on the agenda include the FY 2022 inpatient prospective payment system rule, including graduate medical education policies, and a COVID-19 vaccination payment update.

This call will be by conference call only.  To participate by phone dial 1-888-455-1397 and reference conference passcode 8604468.  Persons participating by phone are not required to RSVP.  TTY Communications Relay Services are available for the hearing impaired.  For TTY services dial 7-1-1 or 1-800-855-2880 and a relay communications assistant will help.  Instant Replay is available by dialing 1-866-346-7095; no passcode needed.

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
FDA will present updates on the Identification of Medicinal Products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification.

Friday, June 11 – FDA
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET   Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how the REMS safety requirements affect prescribers, dispensers and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.