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 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 Tuesday, September 28

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

Provider Relief Fund:  Application Reminder

  • Beginning on September 29, health care providers may 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 will run for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

Provider Relief Fund:  More Information

  • HHS has updated its information on Phase 4 Provider Relief Fund grants and American Rescue Plan grants for rural providers.  The new information includes:
    • Types of eligible providers.
    • An explanation that although general distribution payments will be allocated based on “changes to operating revenue and expenses” from July 1, 2020 to March 31, 2021, the payments can be used to cover eligible lost revenue and expenses incurred from January 1, 2020 through December 31, 2022.
    • The addition of the time period for identifying care provided to individuals living in rural areas:  January 1, 2019 through September 30, 2020.
  • The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 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 grants.  Learn more here and find a link to register to participate.  HRSA has announced that it will hold additional sessions during the weeks of October 11 and October 18; dates and times for those events have not yet been announced.
  • HHS recently hosted a briefing session to provide information about these upcoming funding opportunities.  View a video of that session here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has awarded nearly $1 billion in American Rescue Plan funding to nearly 1300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects.  According to HHS, health centers will use this funding for COVID-19-related capital needs, constructing new facilities, renovating and expanding existing facilities to enhance response to pandemics, and purchasing new state-of-the-art equipment, including telehealth technology, mobile medical vans, and freezers to store vaccines.  Learn more about the funding, its intended use, and how much money was granted to facilities in each state in this HHS news release.
  • Following up on a previously announced commitment, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has announced the distribution of $825 million in federal funds to 231 community mental health centers across the country.  This grant program is intended to enable community mental health centers to more effectively address the needs of individuals who have a serious emotional disturbance or mental illness, often accompanied by substance use disorders.  For a more detailed description of the work the community mental health centers are expected to do with this money and a link to a list of the 231 facilities awarded grants, see this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • Following the FDA’s recent authorization of a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the CDC, CMS will continue to provide coverage for booster doses without cost-sharing.  Beneficiaries with Medicare will pay nothing for COVID-19 vaccines or their administration and there is no copayment, coinsurance, or deductible.  In addition, nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration without cost-sharing.  COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market.  Learn more from this CMS news release.

Health Policy News

  • CMS has posted a special edition of its online newsletter MLN Connects explaining that effective September 20 it is exercising enforcement discretion for skilled nursing facility consolidated billing provisions related to flu and pneumococcal vaccines that enables Medicare-enrolled immunizers, including pharmacies, to bill directly and get direct reimbursement from Medicare, including for vaccine administration and product, whether these vaccines are administered at the same time (co-administered) as a COVID-19 vaccine or at different times.  Find the notice here.

Centers for Disease Control and Prevention

National Institutes of Health

  • The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.  The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses such as COVID-19.  Learn more about the anticipated research and the grant recipients in this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC commissioners met last week to discuss a variety of Medicaid and CHIP payment and access issues, including communicating with beneficiaries, workforce issues, monitoring access to care, health IT adoption among behavioral health providers, and vaccines for adults.  Go here for a summary of the meeting and links to issue briefs prepared to support the commissioners’ discussions.

Government Accountability Office (GAO)

  • The GAO has published a short report that draws from a number of past GAO reports to describe examples of racial and ethnic health disparities, barriers that may contribute to disparities, and federal efforts to help address them.  In this report the GAO cites policy considerations and reiterates recommendations to improve gaps in race and ethnicity data.  Learn more in “GAO Health Care Capsule:  Racial and Ethnic Health Disparities.”
  • In 2016, HHS selected eight states to participate in a time-limited demonstration to establish certified community behavioral health clinics to help improve their response to depression and opioid use challenges within their Medicaid populations.  The GAO has now reviewed the efforts of those states, including the degree to which spending on these services changed during the demonstration period, and has offered recommendations on provider payments and overlap with other Medicaid payments.  Learn more from the GAO report “Medicaid Behavioral Health:  CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication.”

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

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.  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.

HHS/Office of the Assistant Secretary for Preparedness and Response – Grand Rounds for EMS, Critical Care, and Emergency Department ICU Care of Pediatric COVID Patients – September 30

The agency’s “clinical rounds” sessions return on Thursday, September 30 at noon (eastern) with presenters who will discuss emergency management resources and information that can be used to improve operations during the COVID-19 pandemic.  Go here to register to participate in the remote event.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

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 23

The following is the latest health policy news from the federal government as of 3:30 p.m. on Thursday, September 23.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS’s Health Resources and Services Administration has posted new information about planned distributions of additional COVID-19 supplemental funding for health care providers through the Provider Relief Fund and for qualified rural hospitals through funding made available through the American Rescue Plan.  Included in the new posting is information about:
    • Web events to explain what the agency is doing and what providers must do to pursue funding, to be held on Thursday, September 30 and Tuesday, October 5.
    • An application deadline of October 26.
    • What providers are eligible for funding.
    • Documentation grant applicants will need to submit.

Learn more from the updated Provider Relief Fund web page.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS’s Office of the National Coordinator for Health Information Technology has awarded $73 million in cooperative agreement grants as part of its Public Health Informatics & Technology Workforce Development Program to strengthen U.S. public health information technology (IT) efforts, improve COVID-19 data collection, and increase representation of underrepresented communities within the public health IT workforce.  Learn more about how the money will be used and find a list of the grant recipients in this HHS news release.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has granted exceptions for certain Medicare quality reporting and value-based purchasing programs located in areas affected by Hurricane Ida.  These exceptions apply to acute-care hospitals, ambulatory surgical centers, prospective payment system-exempt cancer hospitals, inpatient psychiatric facilities, inpatient rehabilitation facilities, long-term-care hospitals, and skilled nursing facilities in parts of Louisiana, Mississippi, New York, and New Jersey.  Learn more about the exceptions and the specific geographic areas to which they apply in this CMS notice.
  • CMS has published the latest edition of MLN Matters, its online newsletter.  The new edition includes articles about various Medicare billing issues, an update of the ambulatory surgical center payment system, and more.  Find it all here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization for the Pfizer COVID-19 vaccine to allow for use of a single booster dose to be administered at least six months after completion of the primary series in individuals 65 years of age and older; individuals 18 through 64 at high risk of severe COVID-19; and individuals 18 through 64 years whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious complications from COVID-19.  See the FDA announcement and an explanation of the decision here.

Stakeholder Events

MACPAC – September meetings – September 24

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

CDC – Latest CDC Recommendations for Pfizer COVID-19 Booster Vaccination – September 28

The CDC will hold a webinar on Tuesday, September 28 to give clinicians an overview of the Pfizer COVID-19 booster vaccination.  Clinicians will learn about the vaccine booster recommendations, the safety of booster dose, and clinical guidance for using the Pfizer booster vaccine.  Go here for more information about the event and to register to participate.

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

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.  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 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 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 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 Monday, August 30

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

Temporary Suspension of COVID-19 Data Reporting Requirements for Some Hospitals

  • The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has announced that federal hospital COVID-19 reporting requirements for the entire state of Louisiana and parts of Mississippi have been suspended for seven days in response to Hurricane Ida.  While hospitals in the affected areas may still report their data if they wish they are not required to do so and reporting for this period is not expected to be back-filled.  The office will continue to monitor the storm’s impact and this suspension could be extended or expanded to additional areas depending on conditions in the region.

Department of Health and Human Services

  • HHS has declared a state of public emergency in Louisiana and Mississippi because of the effects of Hurricane Ida.  See the HHS announcement for more about what this means.
  • HHS has issued guidance with essential information for states as they navigate the options available to advance COVID-19 vaccination and testing and the Medicaid program’s broader aim of providing health coverage for millions of eligible individuals.  To help states support families and communities and to continue to address health disparities, CMS is providing guidance to states about additional American Rescue Plan funding to promote the importance of COVID-19 vaccination for eligible children and adults enrolled in Medicaid.  Among the areas the new guidance addresses are COVID-19 testing in schools, coverage of habilitation services, enhancing access to COVID-19 vaccines, incentives for states to expand Medicaid, and reducing health disparities.  Learn more from this HHS news release, which includes links to several documents HHS has issued in support of this initiative.
  • HHS has established an Office of Climate Change and Health Equity in response to President Biden’s executive order calling for tackling the climate crisis at home and abroad.  The office is charged with:
    • Identifying communities with disproportionate exposures to climate hazards and vulnerable populations.
    • Addressing health disparities exacerbated by climate impacts to enhance community health resilience.
    • Promoting and translating research on public health benefits of multi-sectoral climate actions.
    • Assisting with regulatory efforts to reduce greenhouse gas emissions and criteria air pollution throughout the health care sector, including participating suppliers and providers.
    • Fostering innovation in climate adaptation and resilience for disadvantaged communities and vulnerable populations.
    • Providing expertise and coordination to the White House, Secretary of Health and Human Services, and federal agencies related to climate change and health equity deliverables and activities, including Executive Order implementation and reporting on health adaptation actions under the United Nations Framework Convention on Climate Change.
    • Promoting training opportunities to build the climate and health workforce and empower communities.
    • Exploring opportunities to partner with the philanthropic and private sectors to support innovative programming to address disparities and health sector transformation.
  • HHS’s Health Resources and Services Administration (HRSA) has extended the deadline for providers, FQHCs, and associations to apply for grants under its “Promoting Resilience and Mental Health Among Health Professional Workforce” program from August 30 to September 20.  $29 million in grant funding is available.  Learn more about the grants and the application process here.
  • HRSA has extended the deadline for applications for another public safety workforce resiliency training program from August 30 to September 20.  This program, which will award up to $68 million in grants, is part of a program to plan, develop, operate, or participate in health professions and nursing training activities using evidence-based or evidence-informed strategies, to reduce and address burnout, suicide, mental health conditions, and substance use disorders and promote resiliency among health care students, residents, professionals, paraprofessionals, trainees, public safety officers, and employers of such individuals in rural and underserved communities.  Learn more about the program and the grant opportunity here.
  • HRSA has awarded $10.7 million from the American Rescue Plan to expand pediatric mental health care access by integrating telehealth services into pediatric care.  Learn more about the programs funded by these resources and the recipients of this grant in this HHS announcement.
  • HRSA will publish a notice in the Federal Register announcing changes in the agency’s organization and operations.  See a pre-publication version of the notice here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online newsletter.  The latest edition has an article on revised ICD-10 code sets, an update on monoclonal antibodies, and more.  Find it here.
  • CMS announced that Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion.  Learn more about the performance of ACOs in the Medicare Shared Savings Program from this CMS news release,
  • CMS has announced three new major appointments:   Dr. Ellen Montz as Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight; Dr. Natalia Chalmers as its first-ever Chief Dental Officer in the Office of the Administrator; and Dara Corrigan as Deputy Administrator and Director of the Center for Program Integrity.  Learn more about the new officials and the positions to which they have been appointed in this CMS news release.

Food and Drug Administration

  • The FDA has approved a first-of-its-kind drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic strokes.  Learn more about this new technology and its application in this FDA news release.

National Institutes of Health

  • The NIH has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.  The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS on that agency’s proposed end-stage renal disease (ESRD) prospective payment system for 2022.  Read its letter here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has posted a fact sheet on Medicaid coverage of qualified residential treatment programs for children in foster care.

Stakeholder Event

MedPAC Meeting – September 2 and 3

MedPAC will hold its September public meetings remotely on Thursday, September 2 and Friday, September 3.  To register to view the Thursday, September 2 session (from 1:15 to 5:15 eastern) go here and to register to view the Friday, September 3 session (9:30 until noon eastern) go here.  To see the agenda for the two sessions and find supporting materials, go here.

 

 

Federal Health Policy Update for Thursday, July 22

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

White House

Centers for Medicare & Medicaid Services

Health Policy News

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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Government Accountability Office

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Stakeholder Events

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

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

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

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

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

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

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

 

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.

Vaccination Rates Low Among Medicaid Recipients

Individuals enrolled in Medicaid are less likely to have received COVID-19 vaccines than the population as a whole, according to a recently published report.

Among the possible reasons for this low rate, observers speculate, is greater vaccine hesitancy among low-income individuals (as identified in a nation-wide survey), less flexible work schedules, and economic barriers such as lack of transportation or child care.

This can pose a special challenge for safety-net hospitals because the communities they serve have more Medicaid beneficiaries than the typical community.

Learn more about the extent of the problem around the country and what state Medicaid programs are doing to encourage more Medicaid beneficiaries to roll up their sleeves and get vaccinated in the Roll Call article “Medicaid beneficiaries less likely to get COVID-19 shots.”