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Federal Health Policy Update for Tuesday, September 21

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

NASH Advocacy

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

Provider Relief Fund

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

The White House

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

National Institutes of Health

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

Stakeholder Events

MACPAC – September meetings – September 23 and 24

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

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

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

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

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

 

Federal Health Policy Update for Monday, 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 Wednesday, July 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, July 14.  Some of the language used below is taken directly from government documents.

CMS – Proposed 2022 Medicare Physician Fee Schedule Rule

CMS has released its proposed Medicare physician fee schedule rule for 2022.  Highlights of the proposed rule, which is more than 1700 pages, include:

  • loosening current restrictions on the use of telehealth and expanding its use for behavioral health services;
  • expanding the reach of the Medicare Diabetes Prevention Program;
  • requiring clinicians to meet a higher performance threshold to receive incentives under the Quality Payment Program;
  • authorizing physician assistants to bill Medicare directly for the Part B services they provide; and
  • phasing out coinsurance for colorectal screening additional services.

In addition, CMS is soliciting stakeholder feedback on health equity data collection and on current Medicare payments for administering vaccines.

For further information about the proposed physician fee schedule rule, see the following resources:

CMS’s news release announcing the newly proposed rule

a CMS fact sheet

quality program update fact sheet

Medicare Diabetes Prevention Program update fact sheet

the proposed rule itself

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 article about cognitive assessment resources for providers, updated FY 2022 ICD-10-CMS codes, and opportunities for web-based training on aspects of Medicare billing.  For this and more, go here.
  • CMS has announced that it will open a National Coverage Determination (NCD) analysis through which it will review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease.  NCDs are program instructions developed by CMS to describe the nation-wide conditions for Medicare coverage for a specific item or service.  This NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the FDA, as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease.  As part of the NCD process, a 30-day public comment period began on July 12.  CMS will host two public listening sessions in July to provide an opportunity for public input.  Learn more from this CMS announcement.
  • CMS has announced that it will distribute $15 million in American Rescue Plan funding to provide community-based mobile crisis intervention services for those with Medicaid.  The $15 million funding opportunity is available to state Medicaid agencies, not providers, for planning grants to support developing these programs.
  • CMS’s Accountable Health Communities (AHC) Model assesses whether bridging the gap between clinical care and social services can reduce health care utilization and costs for Medicare and Medicaid beneficiaries.  In February 2021, CMS hosted its third annual AHC meeting virtually to convene 28 bridge organizations participating in the AHC model and key partners, including community service providers, state Medicaid agencies, and advisory board members.  Meeting participants collaborated and shared insights to sustain their screening, referral, and navigation strategies to address the health-related social needs of Medicare and Medicaid beneficiaries.  Learn more about their insights in the brief “Planning for Sustainability and Advancing Health Equity during the Public Health Emergency.

Provider Relief Fund

Department of Health and Human Services

Health Policy News

  • HHS has provided $398 million in American Rescue Plan money through the Small Rural Hospital Improvement Program to 1540 small rural hospitals for COVID-19 testing and mitigation.  See the HHS announcement here, including a list of how much was distributed to hospitals in each state.
  • HHS’s Health Resources and Services Administration (HRSA) has published a notice in the Federal Register announcing the availability of complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021.  See the HRSA notice here and find the updated lists of HPSAs here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Please note that the vaccine’s FAQ and separate fact sheets translated into other languages have not yet been updated.

Medicaid and CHIP Payment and Access Commission (MACPAC)

Occupational Safety and Health Administration (OSHA)

Office of Management and Budget (OMB)

  • OMB has published its semi-annual work plan presenting its regulatory priorities in the coming months.  Among the HHS matters listed, in addition to those that occur regularly, are:
    • Streamlining the Medicaid and CHIP Application, Eligibility Determination, Enrollment, and Renewal Processes
    • Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration
    • Mandatory Medicaid and CHIP Core Set Reporting
    • Medicaid Managed Care Risk-Sharing Mechanisms
    • Temporary Federal Medical Assistance Percentage (FMAP) increase under the Families First Coronavirus Response Act

See the complete HHS list here.

Stakeholder Events

Thursday, July 15 – Centers for Disease Control

CDC National Call Series on COVID-19-Related Response Strategies

Thursday, July 15 at 2:00 – 3:00 pm ET Click here to join
CDC’s COVID-19 response team conducts a national call weekly to provide state, tribal, local, and territorial (STLT) partners with timely updates and opportunities for peer-to-peer learning and sharing of successful response strategies. Over the summer, these weekly COVID-19 community of practice webinars will focus on topics related to school readiness.

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.

Thursday, July 22 – HHS’s Health Sector Cybersecurity Coordination Center (HC3)
HC3
Cybersecurity Threat Briefing – Qbot/QakBot

Thursday, July 22 at 1:00 pm ET – Click here for registration

HC3 is holding its second July threat briefing, the topic will be “Qbot/QakBot.”  This webinar will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will engage in discussions with participants on current threats and highlight best practices and mitigation tactics.

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.

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

MACPAC kicked off its April meeting with a review of a draft chapter for the June 2021 report to Congress and recommendations on addressing high-cost specialty drugs. Since 2017, the Commission has been working to identify potential models that could help states address the challenges of high prices. The presentation focused on drugs that have been approved by the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Such approvals are based on whether the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit; however, unlike under the traditional pathway, the clinical benefit has yet to be verified.

On Friday, the Commission voted to approve two recommendations* that address Medicaid payment for such drugs. The recommendations would increase the rebates under the Medicaid Drug Rebate Program on accelerated approval drugs until these drugs have verified the clinical benefit. Once the FDA converts the drugs to traditional approval, the rebates would revert back to the standard amounts.

Commissioners then turned their attention to ways states can integrate care through Medicare Advantage dual eligible special needs plans (D-SNPs) using contract authority under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, P.L. 110-275). The draft chapter for the June report describes why MACPAC is focused on D-SNPs, MIPPA strategies available to states, state ability to use these strategies, and MACPAC’s plans for future work on specific strategies that if made mandatory could give further momentum to state efforts.

The Commission then discussed two additional draft chapters for the June 2021 report related to behavioral health services. Staff presented a draft chapter and recommendations on improving access to mental health services for adult Medicaid beneficiaries, followed by a draft chapter and recommendations on improving access to behavioral health services for children and youth.

Commissioners on Friday approved recommendations* that call on the Secretary of the U.S. Department of Health and Human Services to:

  • direct relevant agencies to issue joint subregulatory guidance that addresses how Medicaid and the State Children’s Health Insurance Program (CHIP) can be used to fund a crisis continuum for beneficiaries experiencing behavioral health crises;
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services;
  • direct relevant agencies to issue joint subregulatory guidance that addresses the design and implementation of benefits for children and adolescents with significant mental health conditions covered by Medicaid and CHIP; and
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services.

After a break on Thursday, Commissioners discussed a draft chapter for the June 2021 report to Congress on how electronic health records (EHRs) can be used to strengthen clinical integration and improve patient care.  Adoption of EHRs remains low among behavioral health providers. The chapter provides an overview of MACPAC’s work to date on clinical integration for behavioral and  physical health services, and discusses how data-sharing can improve the quality of care for beneficiaries with behavioral health conditions. It concludes by identifying ways to strengthen EHR uptake among Medicaid’s behavioral health providers.

Next, Commissioners reviewed a draft chapter on non-emergency medical transportation (NEMT). In recent years, policymakers at the state and federal levels have begun to re-examine this benefit. As part of a congressionally mandated request, MACPAC conducted a multi-pronged study of NEMT that will be published as a chapter in the June 2021 report to Congress. This presentation included the key findings of MACPAC’s study and an overview of the topics covered in the draft chapter.

On Friday, the day kicked off with a discussion of the challenges that states face in providing more care through home- and community-based services (HCBS). As of fiscal year (FY) 2018, HCBS spending as a percentage of long-term services and supports spending remained under 50 percent in 18 states and the District of Columbia. To understand why some states have made less progress in rebalancing, MACPAC contracted with RTI International and the Center for Healthcare Strategies. This presentation summarized the results of the work, as well as proposed policy considerations.

The Commission then heard a staff presentation on key Medicaid and CHIP managed care quality requirements, as well as quality improvement and measurement activities conducted by states, plans, and the Centers for Medicare & Medicaid Services. Staff also provided a summary of preliminary findings on state performance over time on selected core set measures and managed care plan performance on performance improvement projects, which suggest the effectiveness of these efforts is unclear. Staff and Commissioners identified potential areas for future MACPAC work related to quality of care in Medicaid and CHIP.

After the Commission voted on several recommendations, staff provided an update on the current state of Transformed Medicaid Statistical Information System (T-MSIS) data submissions and MACPAC’s work to validate and analyze the data. MACPAC found that data submissions have improved since 2016, but some challenges remain.

The meeting concluded with a panel discussion about Medicaid’s use of telehealth services, which expanded during the COVID-19 pandemic. Commissioners heard from Chethan Bachireddy, chief medical officer for the Virginia Department of Medical Assistance Services; Tracy Johnson, Medicaid director for the Colorado Department of Health Care Policy and Financing; and Sara Salek, chief medical officer for the Arizona Health Care Cost Containment System. Panelists described the use of telehealth during the pandemic, considerations for post-pandemic telehealth policies, and challenges to the use and adoption of telehealth in Medicaid and how these states are addressing them.

*All recommendations were approved as presented in draft.

Supporting the discussion were the following briefing papers:

  1. High-Cost Specialty Drugs Review of Draft Chapter and Recommendations
  2. Strategies for State Contracts with Dual Eligible Special Needs Plans
  3. Access to Mental Health Services for Adults: Draft Chapter and Recommendations
  4. Access to Behavioral Health Services for Children and Adolescents: Draft Chapter and Recommendations
  5. Electronic Health Records as a Tool for Integration of Behavioral Health Services
  6. Mandated Report: Non-Emergency Medical Transportation Benefit
  7. Progress on Rebalancing: Lessons from States
  8. Ensuring Medicaid and CHIP Quality
  9. Update on Transformed Medicaid Statistical Information System (T-MSIS)
  10. Panel Discussion: What States are Learning from Expanded Use of Telehealth

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.

MACPAC Issues Recommendations to Congress

The Medicaid and CHIP Payment and Access Commission has submitted its annual report to Congress on Medicaid and the Children’s Health Insurance Program.

The report includes recommendations for:

  • improving Medicaid’s responsiveness during economic downturns
  • addressing concerns about high rates of maternal morbidity and mortality;
  • reexamining Medicaid’s estate recovery policies
  • integrating care for people who are dually eligible for Medicaid and Medicare
  • improving hospital payment policy for the nation’s safety-net hospitals

MACPAC is a non-partisan legislative branch agency that “provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department of Health and Human Services, and the states on a wide array of issues affecting Medicaid and the State Children’s Health Insurance Program (CHIP).”  Its mandate calls for it to address matters such as Medicaid and CHIP payment, eligibility, enrollment and retention, coverage, access to care, quality of care, and the programs’ interaction with Medicare and the health care system generally.

Because safety-net hospitals care for so many more Medicaid and CHIP participants than the typical community hospital, MACPAC’s deliberations are especially important to them.

Learn more about MACPAC’s recommendations in its Report to Congress on Medicaid and CHIP.

MACPAC Looks at Recipients of Provider Relief Fund Grants

What kinds of providers did and did not receive grants from the CARES Act’s Provider Relief Fund?  What were the obstacles to receiving those COVID-19 relief grants and why did some providers fare better in the distribution of Provider Relief Fund resources than others?

These questions and more are addressed in “COVID Relief Funding for Medicaid Providers,” a new analysis released by the Medicaid and CHIP Payment and Access Commission.

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

The October 2020 MACPAC meeting opened with a panel discussion on restarting Medicaid eligibility redeterminations when the public health emergency ends.  It included Jennifer Wagner, director of Medicaid eligibility and enrollment at the Center on Budget and Policy Priorities; René Mollow, deputy director for health care benefits and eligibility at the California Department of Health Care Services; and Lee Guice, director of policy and operations at the Department for Medicaid Services, Kentucky Cabinet for Health and Family Services.

After a break, Commissioners heard a panel discussion with Kevin Prindiville, executive director at Justice in Aging; Mark Miller, executive vice president of healthcare at Arnold Ventures; and Charlene Frizzera, senior advisor at Leavitt Partners, on creating a new program for dually eligible beneficiaries. Later, staff presented preliminary findings from a mandated report on non-emergency medical transportation. The day concluded with a report on nursing facility acuity adjustment methods.

On Friday, the day began with a session on access to mental health services for adults in Medicaid. It was followed by a related panel discussion on mental health services with Sandra Wilkniss, director of complex care policy and senior fellow at Families USA; Melisa Byrd, senior deputy director for the District of Columbia Department of Health Care Finance; and Dorn Schuffman, director of the CCBHC Demonstration Project at the Missouri Department of Mental Health.

Next, the Commission considered the merits of extending Medicaid coverage for pregnant women beyond 60 days postpartum. Staff then provided an update on a statutorily required analysis of disproportionate share hospital (DSH) allotments, as well as an analysis of addressing high-cost drugs and the challenges they present to Medicaid.

The meeting concluded with comment on the Secretary’s report to Congress on Reducing Barriers to Furnishing Substance Use Disorder (SUD) Services Using Telehealth and Remote Patient Monitoring for Pediatric Populations under Medicaid. The Commission decided to send a letter to Congress and the Secretary commenting on this report.

Supporting the discussion were the following briefing papers:

  1. Mandated Report on Non-Emergency Medical Transportation: Work Plan and Preliminary Findings
  2. Changes in Nursing Facility Acuity Adjustment Methods
  3. Access to Mental Health Services for Adults in Medicaid
  4. Considerations in Extending Postpartum Coverage
  5. Required Annual Analysis of Disproportionate Share Hospital (DSH) Allotments
  6. Addressing High-Cost Drugs and Pipeline Analysis
  7. Comment on Secretary’s Report to Congress on Reducing Barriers to Substance Use Disorder Services Using Telehealth for Pediatric Populations under Medicaid

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

The February 2020 MACPAC meeting opened with a continuation of MACPAC’s examination of Medicaid’s role in maternal health, when Medicaid officials from Michigan, New Jersey, and North Carolina joined the Commission to discuss how their states are addressing maternal morbidity and mortality.* The Commission plans to include a chapter on maternal health in its June 2020 report to Congress. Commissioners later turned their attention to policy options for improving enrollment in the Medicare Savings Program.

The Commission later took a deep dive into value-based payment in Medicaid managed care. This three-part session began with findings from a series of interviews with state officials, managed care organizations, and other stakeholders aimed at understanding how states use managed care to promote payment reform, conducted by MACPAC contractor Bailit Health. Then, representatives from three of these organizations shared their reactions to the findings and talked about how value-based payment models are working in practice.* The session concluded with Commissioners’ perspectives on the study’s findings and the panelists’ reactions to them, and possible next steps.

The final session of the afternoon continued a line of inquiry begun at the October 2019 meeting: third-party liability coordination between Medicaid and TRICARE. MACPAC estimates that almost 1 million Medicaid enrollees have primary coverage through TRICARE, which provides health benefits for military personnel, military retirees, and their dependents. Commissioners explored making recommendations in the June report to improve coordination between the two programs.

On Friday, the Commission returned to the theme of improving care for dually eligible beneficiaries, looking more closely at the rise of so-called dual-eligible special needs plan (D-SNP) look-alikes and how changes in the Medicare Advantage market are affecting efforts to integrate care. Commissioners also reviewed a rule proposed in February that would, among other things, restrict the growth of look-alikes.

Following that session, the Commission discussed draft recommendations to improve integration of Medicare and Medicaid benefits for dually eligible beneficiaries. The February meeting wrapped up with a discussion of a forthcoming rule expected to affect the Medicaid eligibility determination process.

Supporting the discussion were the following briefing papers:

  1. State Medicaid Initiatives to Improve Maternal Health
  2. Improving Participation in the Medicare Savings Programs: Decisions on Draft Recommendations for the June Report to Congress
  3. State Strategies to Promote the Use of Value-Based Payments in Medicaid Managed Care
  4. Medicaid and TRICARE: Third-Party Liability Coordination
  5. How Changes in the Medicare Advantage Market Are Affecting Integration of Care for Dually Eligible Beneficiaries: Analysis and Comments on Proposed Rule
  6. Improving Integrated Care for Dually Eligible Beneficiaries: Decisions on Recommendations to be Included in June Report to Congress
  7. Forthcoming Rule on Program Integrity and Eligibility Determination Processes

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.

MACPAC Looks at Medicaid DSH

At a time when cuts in Medicaid disproportionate share hospital payments (Medicaid DSH) are still scheduled for the current fiscal year and some in Congress are calling for a new approach to allotting DSH funds among the states, the Medicaid and CHIP Payment and Access Commission has released its annual analysis of Medicaid DSH allotments to the states.

The report includes:

  • data about changes in the uninsured rate
  • demographic information about the uninsured
  • information about the cost of hospital uncompensated care
  • perspectives on hospital Medicaid shortfalls
  • a comparison of hospital uncompensated care costs when calculated using different methodologies
  • data about hospitals that provide “essential community services”
  • information about scheduled Medicaid DSH allotment reductions

All private safety-net hospitals receive Medicaid DSH payments and consider the program an essential tool for serving their communities.

MACPAC will issue a more complete report to Congress in March of 2020.

Learn more about how MACPAC views Medicaid DSH at a time when the program is scheduled to change – and when some want even more change – in the new MACPAC document “Required Analyses of Disproportionate Share Hospital (DSH) Allotments.”